Hyperthermia Pump, 120V 902-00001Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10896128002456), received between Apr 20, 2018 and Aug 13, 2021 — classified as 24 malfunctions.

The most frequently reported specific device problem is “Circuit Failure” (2 reports).

3 other recalls cover devices cleared under the same FDA submission (K152208); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 13, 2021No Apparent Adverse Event; No Apparent Adverse Event

  BELMONT'S CLINICAL SPECIALIST RECEIVED A REPORT INVOLVING A HYPERTHERMIA PUMP AND RELAYED THE FOLLOWING: "RECEIVED A PHONE CALL FROM (B)(6) TO NOTIFY BELMONT THAT AFTER A HYPOTHERMIA CASE, A PATIENT HAD LESIONS LEFT ON THE BOWEL. THE LESIONS WERE NOTICED WHEN THE PATIENT'S ABDOMEN WAS OPENED AND THE CANNULAS HAD BECOME ATTACHED TO THE BOWEL OF THE PATIENT FROM THE SUCTION. THE DEVICE WAS BEING OPERATED BY (B)(6), PERFUSIONIST, AND THE SUCTION WAS NOT TURNED DOWN PRIOR TO CONNECTING IT TO THE CANNULAS."

  Patient problems: Adhesion(s); Bruise/Contusion

  MAUDE report 12321736 ↗
• MalfunctionJul 9, 2021No Apparent Adverse Event; No Apparent Adverse Event

  THE USER FACILITY REPORTED THAT THE HYPERTHERMIA PUMP VACUUM REGULATOR STOPPED WORKING INTERMITTENTLY DURING THE LAST SEVERAL HYPERTHERMIA PROCEDURES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12146548 ↗
• MalfunctionJun 25, 2021Circuit Failure; Circuit Failure

  THE USER FACILITY REPORTED THAT THE HYPERTHERMIA PUMP EXHIBITED A SYSTEM ERROR 204 (HEATER POWER I/O FAULT ALARM) AT THE BEGINNING OF A HYPERTHERMIC PROTOCOL CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12071892 ↗
• MalfunctionJun 1, 2021Intermittent Loss of Power; Intermittent Loss of Power

  THE USER FACILITY REPORTED THAT THE HYPERTHERMIA PUMP WAS FREQUENTLY SHUTTING DOWN A CASE. ANOTHER HYPERTHERMIA PUMP WAS BROUGHT IN TO FINISH THE CASE. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11917100 ↗
• MalfunctionApr 29, 2021Pressure Problem; Temperature Problem; Pressure Problem; Temperature Problem

  THE PHYSICIAN REPORTED THAT DURING A CASE, THE HYPERTHERMIA PUMP EXHIBITED FREQUENT TEMPERATURE ERRORS AND ALARMED "HIGH PRESSURE" AT A FLOW RATE OF 600ML/MIN WHEN THE SCREEN DISPLAYED A PRESSURE READING OF ONLY 150 MMHG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11750030 ↗
• MalfunctionApr 21, 2021Insufficient Heating; Insufficient Heating

  THE USER REPORTED THE FOLLOWING ABOUT A HYPERTHERMIA PUMP: "WHEN RUNNING HYPERTHERMIA MACHINE DURING A CASE, I RECEIVED A HEATING FAULT ALARM ON THE DEVICE WHEN INCREASING THE TARGET TEMPERATURE. I TURNED OFF THE DEVICE AND WIPED DOWN TEMP SENSORS, AND REBOOTED MACHINE, AND RECEIVED THE SAME ERROR MESSAGE WHEN DEVICE REACHED 40.5C. I THEN CHANGED OUT THE HEAT EXCHANGER KIT AND THEN REBOOTED MACHINE AGAIN AND THE ISSUE WAS RESOLVED FOR THE REST OF THE CASE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11704330 ↗
• MalfunctionApr 9, 2021Pumping Stopped; Pumping Stopped

  BELMONT'S SALES REPRESENTATIVE RECEIVED A REPORT FROM THE PHYSICIAN THAT THE HYPERTHERMIA PUMP STOPPED 40 MINUTES INTO A CASE AND DISPLAYED A PUMP FAILURE ON THE SCREEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11646239 ↗
• MalfunctionApr 2, 2021Failure to Pump; Failure to Pump

  DURING A HYPERTHERMIA CASE, THE HYPERTHERMIA PUMP EXHIBITED A "PUMP FAULT" ALARM AT START-UP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11610401 ↗
• MalfunctionMar 3, 2021Incorrect Measurement; Incorrect Measurement

  THE USER FACILITY REPORTED THAT THE HYPERTHERMIA PUMP DISPLAYED INCORRECT TEMPERATURE OUTPUTS AT LOCATIONS T1, T2, AND T3.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11408165 ↗
• MalfunctionFeb 25, 2021Restricted Flow rate; Excessive Heating; Restricted Flow rate; Excessive Heating

  BELMONT'S SALES REPRESENTATIVE RECEIVED A REPORT FROM THE USER FACILITY INVOLVING A HYPERTHERMIA PUMP AND REPORTED THE FOLLOWING: "DURING CASE THEY RECEIVED LIMITED RETURN FLOW AND WERE UNABLE TO MAINTAIN A HIGH RATE OF PERFUSION. AT THE END OF THE CASE THEY FLUSHED THE PATIENT WITH 6 L OF STERILE WATER AND RECEIVED A HIGH TEMPERATURE ALARM. FLOW WAS PAUSED TO LET MACHINE COOL BEFORE CONTINUING WITHOUT ISSUE. DOCTOR SUGGESTED IT COULD HAVE BEEN A ONE OFF SITUATION BUT I'VE ASKED PERFUSION FOR THE DISPOSABLE LOT NUMBER AND WILL UPDATE WITH ADDITIONAL INFORMATION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11381830 ↗
• MalfunctionFeb 18, 2021No Visual Prompts/Feedback; No Visual Prompts/Feedback

  THE USER FACILITY REPORTED THAT THE HYPERTHERMIA PUMP SCREEN FROZE DURING A PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11346715 ↗
• MalfunctionNov 6, 2020Power Problem; Power Problem

  THE USER FACILITY REPORTED THAT WHILE THE HYPERTHERMIA PUMP WAS IN USE, THE USER EXPERIENCED A BATTERY OPERATE ERROR INTERMITTENTLY BUT WAS ABLE TO FINISH THE CASE AFTER ADJUSTING THE POWER CORD AND REPOWERING THE UNIT. DURING TROUBLESHOOTING, THE HOSPITAL BIOMED WAS ABLE TO CONFIRM A LOOSE CONNECTION BETWEEN THE POWER CORD AND THE POWER ENTRY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10805369 ↗
• MalfunctionSep 4, 2020Circuit Failure; Circuit Failure

  THE USER FACILITY REPORTED THAT THE HYPERTHERMIA PUMP WAS EXHIBITING "HEATER POWER I/O FAULT" ALARMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10497365 ↗
• MalfunctionAug 14, 2020Display or Visual Feedback Problem; Display or Visual Feedback Problem

  BELMONT'S SALES REPRESENTATIVE RECEIVED A COMPLAINT FROM THE USER FACILITY AND RELAYED THE FOLLOWING REPORT: "DURING PROCEDURE, T2 DID NOT DISPLAY TEMPERATURE ON SCREEN. PATIENT UNHARMED AND DID NOT DELAY PATIENT CARE."

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10411179 ↗
• MalfunctionJun 4, 2020Material Twisted/Bent; Material Twisted/Bent

  BELMONT'S CLINICAL SPECIALIST RECEIVED A COMPLAINT FROM THE USER FACILITY AND RELAYED THE FOLLOWING REPORT: "DURING THE CASE ON (B)(6) 2020, A CONTINUOUS HI-PRESSURE ALARM WAS RECEIVED DURING THE CASE. GREG CHECKED THE TUBING BETWEEN THE BELMONT HYPOTHERMIA PUMP AND THE PATIENT WITHOUT FINDING A KINK. HE SAID THE PRESSURE WAS AROUND 170 MMHG, SO I HAD HIM CHECK THE TUBING BETWEEN THE 4.4-LITER CANISTER AND THE TOP OF THE MACHINE. HE FOUND SOME KINKS, AFTER APPLYING PRESSURE TO THE KINKS TO ROUND THEM OUT, THE ALARMS QUIT. THE CASE WAS FINISHED WITHOUT INCIDENT."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10121863 ↗
• MalfunctionMar 25, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  BELMONT'S DISTRIBUTOR RECEIVED A COMPLAINT FROM THE USER FACILITY AND REPORTED THE FOLLOWING: WHILE THE PERFUSIONIST WAS PRIMING THE HYPERTHERMIA PUMP, THE UNIT EXHIBITED ERROR #208 ("VALVE FAULT" ALARM). THE USERS CLOSED THE UNIT AND ATTEMPTED TO RESTART IT, BUT THE PROBLEM PERSISTED. ANOTHER UNIT WAS BROUGHT IN TO FINISH THE CASE; THE USERS WERE ABLE TO REUSE THE SAME DISPOSABLE KIT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9880565 ↗
• MalfunctionFeb 21, 2020Communication or Transmission Problem; Communication or Transmission Problem

  BELMONT'S CLINICAL SPECIALIST RECEIVED A COMPLAINT FROM THE USER FACILITY AND RELAYED THE FOLLOWING REPORT: "I RECEIVED AN AFTER HOURS CALL CONCERNING AN ISSUE WITH A HYPERTHERMIA PUMP AND NOT HAVING ANY TEMPERATURE READINGS. UPON CALLING THEM BACK I SPOKE WITH (B)(6) AND SHE TOLD ME THAT NONE OF THE FOUR TEMPERATURE READINGS WERE SHOWING ON THE HYPERTHERMIA MACHINE SHE WAS USING. I ASKED FOR HER TO ATTACH ANESTHESIA'S TEMPERATURE CABLE TO THE PROBES IN ORDER TO DETERMINE IF THE ISSUE WAS WITH THE PROBES, CABLES OR MACHINE. SHE SAID SHE WOULD DO THAT AND FOLLOW UP WITH REPAIR OF THE MACHINE IF IT WAS DETERMINED THAT IT WAS NECESSARY."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9741132 ↗
• MalfunctionFeb 19, 2020Temperature Problem; Temperature Problem

  BELMONT'S CLINICAL SPECIALIST RECEIVED A COMPLAINT FROM THE USER FACILITY AND RELAYED THE FOLLOWING REPORT: "THE DOCTOR WAS EXPERIENCING AN ERROR 204, HEATER POWER I/O FAULT DURING THE HIPEC CASE. AT THE TIME HE WAS CHANGING THE TARGET TEMP FROM 45 C TO 48 C AT MAX FLOW RATE OF 1000 ML/MIN. THE UNIT WAS RECENTLY SENT BACK IN OCTOBER 2019 WITH OUTPUT TEMP BEING DROPPED BUT BELMONT REPAIR TECH WAS UNABLE TO DUPLICATE OR CONFIRM THE ISSUE."

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 9729804 ↗
• MalfunctionNov 13, 2019Display or Visual Feedback Problem; Display or Visual Feedback Problem

  THE USER FACILITY REPORTED THAT THE TOUCH SCREEN BECAME UNRESPONSIVE DURING A HYPERTHERMIA CASE. THE MACHINE WAS TURNED OFF AND RESET BY PERFUSION AND THE SCREEN BECAME UNRESPONSIVE. THE CASE WAS FINISHED WITH THE ISSUE OCCURRING AGAIN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9319043 ↗
• MalfunctionMay 24, 2019Device Alarm System; Device Alarm System

  BELMONT'S SALES REPRESENTATIVE RECEIVED A COMPLAINT FROM THE USER FACILITY AND RELAYED THE FOLLOWING REPORT: "DURING CASE AN AUDIBLE ALARM CONTINUOUSLY SOUNDED WITHOUT PROVIDING ERROR MESSAGE ON SCREEN. TEMPERATURES, PRESSURE AND FLOW RATE ALL REMAINED STABLE WHILE ALARMING. THIS OCCURRED ROUTINELY DURING MACHINE PERIODIC RE-PRIME AND RANDOMLY THROUGHOUT PROCEDURE."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8642897 ↗
• MalfunctionApr 28, 2019Intermittent Loss of Power; Intermittent Loss of Power

  OUR DISTRIBUTOR RECEIVED A COMPLAINT FROM THE USER FACILITY AND REPORTED THAT DURING A CASE, THE UNIT TURNED OFF BY ITSELF DURING THE PRIMING PROCESS. THE STAFF WAS UNABLE TO POWER IT BACK ON. ANOTHER UNIT WAS BROUGHT IN TO FINISH THE CASE AND THE PATIENT WAS NOT HARMED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8559629 ↗
• MalfunctionMar 8, 2019Mechanical Problem; Mechanical Problem

  THE USER FACILITY REPORTED THAT THE HYPERTHERMIA PUMP EXHIBITED A "PUMP FAULT" ALARM. BELMONT'S SALES REPRESENTATIVE SPOKE WITH THE CHIEF PERFUSIONIST AND RELAYED THE FOLLOWING REPORT: "WE WERE ON ABOUT 40 MINUTES WARMING AND WAITING FOR THE CHEMO FROM PHARMACY. ABOUT TWO MINUTES AFTER I PUT THE CHEMO IN THE PUMP IT STARTED MAKING A LOUD CLICKING NOISE. I TURNED IT OFF IMMEDIATELY AND WHEN BRIAN AND I LOOKED OVER NOTICED A SILVER PIN ABOUT 1 1/2 INCHES LONG LAYING IN BEHIND THE PUMP. I CLAMPED ALL THE LINES, OPENED THE DOOR AND UNLOADED ALL THE DISPOSABLES FROM THE RACEWAY TO GET ACCESS TO THE ROLLER HEAD. I COULD SEE THE LOOSE ROLLER HINGE AND WAS ABLE TO GET THE PIN BACK IN. I PUT THE DISPOSABLES BACK IN AND RELOADED EVERYTHING. TOOK THE CLAMPS OFF AND WENT BACK ON. ONLY OFF ABOUT 30-45 SECONDS. IT WORKED FINE BUT EVERY 30 MINUTES OR SO THE PIN WOULD START WORKING BACK OUT BUT I COULD TAP IT BACK IN WITHOUT STOPPING THE PUMP."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8405927 ↗
• MalfunctionMay 22, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE UNIT LOST POWER DURING A CASE. ANOTHER HYPERTHERMIA PUMP WAS BROUGHT IN AND THE CASE WAS FINISHED SUCCESSFULLY. NO INJURY TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7534848 ↗
• MalfunctionApr 20, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE USER FACILITY REPORTED THAT THE HYPERTHERMIA PUMP EXHIBITED A HEATING FAULT ALARM WITH THE FOLLOWING ALARM MESSAGE: "CHECK TEMPERATURE PROBE WINDOWS FOR BLOCKAGE." THE MACHINE WAS REBOOTED AND THE PROCEDURE PROCEEDED AS PLANNED. NEAR THE END OF THE CASE, THE UNIT EXHIBITED ANOTHER HEATING FAULT ALARM. THERE WAS NO ADVERSE IMPACT TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7449143 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K152208. One submission often covers many models, so check the product and lot details in each record.

• Z-1675-2025 · Mar 31, 2025 · Open, Classified
  Straight Inflow/Outflow Patient Line Kit. Model Number: 902-00037. Sterile, single-use, disposable set used with the Hyperthermia Pump. The Straight Inflow/Outflow Patient Line
• Z-1676-2025 · Mar 31, 2025 · Open, Classified
  Straight Inflow/Bifurcated Outflow Line Kit. Model Number: 902-00038. Sterile, single-use, disposable set used with the Hyperthermia Pump. The Straight Inflow/Outflow Patient L
• Z-1674-2025 · Mar 31, 2025 · Open, Classified
  Hyperthermia Pump Procedure Kit. Model Number: 902-00045. Sterile, single-use, disposable set used with the Hyperthermia Pump. The Hyperthermia Procedure kit (P/N 902-00045) co