CASE REPORTS

Overheating and Rupture of FMS 2000 Rapid Infuser

Victor W. Xia, MD, Marc Huh, BS, Nishi Ross, Hamid Nourmand, MD, Cynthia Wang, MD, and
Randolph H. Steadman, MD

A TRANSFUSION DEVICE equipped with a warming unit is a

crucial tool for rapid blood transfusion in clinical settings such as
liver transplantation and cardiac and trauma surgeries. Among many
similar devices, the Belmont FMS 2000 Rapid Infuser (Belmont
Instrument Corporation, Billerica, MA) is one of the most widely
used since its introduction in 1999. Despite its user-friendly design
and high performance,1-4 malfunctions of this device have been re-
ported.3 Between June 2009 and August 2010, the authors encoun-
tered 12 cases in which the warming unit of the FMS 2000 Rapid
Infuser became overheated during rapid transfusion. Two of the 12
overheated warming units ruptured. In an attempt to identify the cause
of the problem, the authors performed a series of experiments on the
FMS 2000 Rapid Infuser. Twelve cases (one in detail) and the results
of the authors’ investigation are reported here. Recommendations for
management of this problem are also provided.

CASE REPORT
All 12 cases occurred in adult patients during liver transplant surgery. The
mean patient age was 58 years (range, 49-69). A standard anesthetic technique
was provided for all liver transplants. The patients were induced with mida-
zolam, fentanyl, propofol, and succinylcholine and maintained with inhalation
and intravenous anesthetics. The FMS 2000 Rapid Infusers were primed with
500 mL of normal saline per the authors’ standard practice. Packed red blood
cells, fresh frozen plasma, and human albumin were the only products placed
in the reservoirs of the infusers. Overheating or rupture of the warming units
of the FMS 2000 Rapid Infusers was noticed during blood transfusion. After
overheating was noted, one of the following actions was eventually taken:
exchange of the insert (the warming unit included), replacement of the Rapid
Infuser, or discontinuation of use of the Infuser if the patient’s condition
allowed. No obvious or specific adverse effect was observed in the 12 patients.
The mean red blood cells transfused were 17 units (range, 3-39), and the mean
fresh frozen plasma transfused was 22 units (range, 5-52).
The authors report the following case in detail. A 61-year-old man
with end-stage liver disease secondary to nonalcoholic steatohepatitis Fig 1. The overheated warming unit of the FMS 2000 Rapid In-
presented for liver transplantation. The patient was induced, and sur- fuser is deformed and ruptured. (Color version of figure is available
online.)
gery was started without any problem. The Belmont FMS 2000 Rapid
Infuser was prepared and used during the liver transplant case. About
2 hours into its use, the FMS 2000 Rapid Infuser alarmed. At the same
time, an overheating message appeared on the display, and the infusion for immediate blood resuscitation, the infusion resumed. A few minutes
was automatically stopped. Because of rapid blood loss and the need later, the overheating alarm sounded again, and the device was turned
off and back on a few times until the warming unit was found to be
extremely hot, deformed, and ruptured on the left side (Fig 1). At this
From the Department of Anesthesiology, Ronald Reagan UCLA point, a replacement FMS 2000 device with a new disposable warming
Medical Center, David Geffen School of Medicine at UCLA, Los unit was used. For the remainder of the operation, the new infuser
Angeles, CA. functioned without problems. For the entire surgery, a total of 14 units
Address reprint requests to Victor W. Xia, MD, Department of of red blood cells, 16 units of fresh frozen plasma, and 750 mL of
Anesthesiology, Ronald Reagan UCLA Medical Center, David Geffen albumin were transfused via the 2 FMS 2000 Rapid Infusers.
School of Medicine at UCLA, 757 Westwood Plaza, Suite 3325, Los Among 12 overheated warming units, 2 were sent to the manufac-
Angeles, CA 90095-7430. E-mail: vxia@mednet.ucla.edu turer for analysis. The units were washed with 50 mL of saline, and
© 2011 Elsevier Inc. All rights reserved. effluents were collected and analyzed. Calcium was detected in both
1053-0770/2506-0031$36.00/0 samples (concentrations: 0.4 mg/dL and 2.3 mg/dL). D-dimer (195
doi:10.1053/j.jvca.2010.12.002 ng/mL) and fibrinogen (⬍35 mg/dL) only were found on 1 of the 2
Key words: rapid transfusion, overheating, rupture samples. Analysis concluded that “procoagulant was allowed to enter

1092 Journal of Cardiothoracic and Vascular Anesthesia, Vol 25, No 6 (December), 2011: pp 1092-1094
FMS 2000 RAPID INFUSER 1093

the infusion system, likely resulting in clot forming within the heat gested that extended running times and high pressures alone
exchanger and subsequent high temperature leading to partial melting were unlikely to be the cause because the device ran for more
of the exchanger.” After the first several overheating cases, the authors than 24 hours under a high pressure without any problems
performed a series of experiments to identify the cause of overheating. (experiments 1 to 3). The units of red blood cells transfused in
A new disposable warming unit along a randomly chosen FMS 2000
the cases varied greatly, and pressures in those cases were not
Rapid Infuser was used for each experiment. During the experiments,
the output tubing of the infuser was connected back to the reservoir to
always high. Device malfunction did not seem to be a cause of
allow the infuser to run continuously without adding fluids. No patient the problem either because the incidences occurred in the old
was involved in any of the experiments. In experiment 1, the authors machines (7 years of usage since 2003) as well as new ones
primed the FMS 2000 Rapid Infuser with normal saline and ran the (under a loan program from the manufacturer).
infuser over 24 hours. In experiment 2, the authors primed the infuser Blood clots were found inside of the overheated warming
with normal saline, added a pressure (250 mmHg) to the infuser by units upon gross examination and laboratory analysis. Calcium
partially occluding the output tubing, and ran the infuser continuously. and D-dimer found on analysis were used as evidence to
In experiment 3, the authors primed with normal saline, added expired support the claim that procoagulant (most likely calcium) was
packed red blood cells (2 units) and fresh frozen plasma (2 units), and
introduced into the infuser. Complete occlusion of a section of
ran the infuser continuously under the pressure. Overheating was not
the warming units caused by the procoagulant and then clots
detected during any of the 3 experiments. In experiment 4, the authors
repeated experiment 3 and added 500 mL of lactated Ringer’s solution were suspected as causes of overheating by the manufacturer.3
into the reservoir during the testing. Overheating was not noticed However, in the present case, the overheated warming units
during a 3-hour experiment after adding lactated Ringer’s solution. were analyzed a few days after the incident. Such late analysis
Then, 300 mg of calcium chloride were added into the reservoir, and may reflect reactions after and not during the overheating
massive blood clots were noticed immediately in the reservoir. The incident. Although a trace amount of calcium and D-dimer
Rapid Infuser stopped because of the massive clots that had formed in were found in the samples extracted from the warming unit, an
the reservoir, and flow through the warming unit of the infuser ceased. interpretation of absolute values without controls is difficult.
Although a possibility of an accidental introduction of calcium
DISCUSSION
into the unit could not be completely ruled out, it was very
Between June 2009 and August 2010, the authors observed unlikely. The authors’ center, one of the largest liver transplant
12 cases in which the warming units of the FMS 2000 Rapid programs in the United States, has never knowingly placed any
Infuser became overheated (2 of which resulted in rupture) drugs or calcium-containing fluids (lactated Ringer solution) in
during normal use. Although the problem of overheating has the reservoir of the infuser. In experiment 4, lactated Ringer
been described in the literature, the authors believed this prob- solution had been added into the reservoir for 3 hours, and
lem was underappreciated. The overheated transfusion device overheating did not occur. If clots formed before overheating, they
exposes the patients to potential hazards. Automatic cessation would have formed evenly on both sides of the coil. The fact that
of the transfusion in response to overheating can leave patients the clots were found consistently on the left side of the coils while
underresuscitated during massive blood loss. Hemolysis caused
by excessive heat can lead to a number of serious medical
problems, such as systemic and pulmonary vasoconstriction,
coagulopathy, hyperkalemia, and renal injury.5-8 Overheating
also can lead to the release of leukocyte free radicals and
vasoactive mediators as well as activation of the complement
system.3 Finally, rupture of the plastic housing violates integ-
rity of the warming unit and exposes the patients to an in-
creased risk of bacterial and other contaminants.
The warming unit of the FMS 2000 Rapid Infuser contains a
metal coil that is used to magnetically induce heat. The FMS
2000 Rapid Infuser is capable of generating an enormous
amount of energy to warm a large quantity of cold blood during
rapid transfusion to prevent hypothermia. The warming unit is
designed to automatically adjust the heat according to the
inflow temperature and the fluid passing through the coil. A
temperature sensor monitors the blood temperature as it leaves
the coil and engages an alarm when the blood reaches 42°C.3
Once the alarm is engaged, heating and pumping stops, and an
alert message is displayed. The temperature required to deform
the coil is 100°C.3 It is reasonable to believe that the temper-
ature required for rupture is even higher.
In the authors’ speculation, factors that would cause over-
heating of the warming unit include extended running time,
Fig 2. A drawing of the warming unit of FMS 2000 Rapid Infuser.
increased pressure in the output tubing, device malfunction, The left side is affected (overheated and the plastic housing may
clot formation inside of the warming unit, and usage of a become deformed or rupture), whereas the right side is relatively
defective warming unit. The preliminary experiments sug- normal.
1094
the right side appeared normal in the present series suggested that
overheating may appear before clot formation (Fig 2).
Excessive heat, such as cauterization, can cause clot forma-
tion. The authors suspect that overheating occurred before clot
formation and heat was concentrated on the left side of the coil,
leaving that side more vulnerable. Excessive heat could then
cause deformation and rupture of the warming unit. When 1
side of the coil is overheated and another side is normally
heated, the following problems can potentially occur: (1) the
affected side of the coil can get extremely hot or even rupture;
(2) efficacy of transfusion may be reduced significantly because
only half of the channels are open; and (3) before complete
obstruction of flow, some overheated and damaged red blood
cells can pass through and reach the patient.
In conclusion, in this a series, the authors report 12 cases of
REFERENCES
1. Comunale ME: A laboratory evaluation of the level 1 rapid
infuser (H1025) and the Belmont instrument fluid management system
(FMS 2000) for rapid transfusion. Anesth Analg 97:1064-1069, 2003
2. Schumann R: Intraoperative resource utilization in anesthesia for
liver transplantation in the United States: A survey. Anesth Analg
97:21-28, 2003
3. Husser CS, Chamblee B, Brown MJ, et al: Inductive warming of
intravenous fluids: overheating of the toroid heating element during
rapid infusion. Anesthesiology 101:1019-1021, 2004
4. Dubick MA, Brooks DE, Macaitis JM, et al: Evaluation of com-
mercially available fluid-warming devices for use in forward surgical
and combat areas. Mil Med 170:76-82, 2005
XIA ET AL
overheating or ruptured warming units of the FMS Rapid
Infuser during liver transplantation and preliminary data from
the experiments performed on the Rapid Infuser. Unfortu-
nately, a definitive cause of overheating was not identified.
Therefore, further studies are warranted, especially those in
which cold fluids are used to activate the warming process of
the device continuously to simulate a real clinical situation. In
the meantime, the authors recommend the following: (1) when
using the FMS 2000, clinicians need to be aware of a possibility
of overheating during routine use; (2) the manufacturer should
publish a safety advisory and redesign the overheating warning
message so that the warning remains displayed until the warm-
ing unit is replaced; and (3) physicians and medical staff
operating the FMS 2000 should immediately replace the device
once the overheating warning appears.
5. Hendrickson JE, Hillyer CD: Noninfectious serious hazards of
transfusion. Anesth Analg. 108:759-769, 2009
6. Cappellini MD: Coagulation in the pathophysiology of hemo-
lytic anemias. Hematology Am Soc Hematol Educ Program 74-78,
2007
7. McCullough J, Polesky HF, Nelson C, et al: Iatrogenic hemolysis:
A complication of blood warmed by a microwave device. Anesth Analg
51:102-106, 1972
8. Sloan TB, Myers G, Janik DJ, et al: Intraoperative auto-
logous transfusion of hemolyzed blood. Anesth Analg 109:38-42,
2009