Hemotherm 400CERecalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 10613031860221), received between May 8, 2019 and Nov 8, 2023 — classified as 30 malfunctions.

The most frequently reported specific device problem is “Insufficient Heating” (8 reports).

1 FDA recall record name this device's identifier.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Sep 4, 2018Terminated

   Potential for membrane (control panel) switch errors leading to an inability of the device to change control settings or an unintended change to control settings.

   Z-0063-2019 · Root cause: Device Design · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 8, 2023Insufficient Heating; Insufficient Heating

  CUSTOMER REPORTS: "WE HAD AN ISSUE WITH ONE OF OUR HEMOTHERM (B)(4) UNITS (S/N (B)(6), VA BIOMED EE 194-11307CE) YESTERDAY DURING OUR CASE. UPON REWARMING THE PATIENT/UNIT, THE WARM SIDE WOULD NOT GO ABOVE 34 DEGREES. WE SWITCHED OUT UNITS TO CONTINUE REWARMING OUR PATIENT. THERE WAS NOT ANY ALARM ON THE AFFECTED UNIT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18090867 ↗
• MalfunctionJul 14, 2021Output Problem

  THE PERFUSIONIST HAD THE PATIENT ON BYPASS AND NOTICED TEMPERATURE OF THE PATIENT WAS LOW, THE DEVICE SET POINT WAS AT 37 BUT THE ACTUAL TEMPERATURE WAS 32. THE CUSTOMER CHECKED THE FLOW INDICATOR AND IT WAS SHOWING FORWARD FLOW. THE DEVICE WAS CHANGED OUT WITH BLANKETROL DEVICES WITHOUT INCIDENT. THE HEMOTHERM 400CE DEVICE WAS SENT TO BIOMED TO HELP DIAGNOSE ISSUE. BIOMED DETERMINED THE HEATING ELEMENT WAS NOT FUNCTIONING.

  Patient problems: Alteration in Body Temperature

  MAUDE report 12170349 ↗
• MalfunctionJul 14, 2021Display or Visual Feedback Problem; No Flow

  CUSTOMER CLAIMS THEIR HEMOTHERM 400CE WAS NOT FLOWING AND FROZE UP DURING A PROCEDURE; "THE PERFUSIONIST HAD BEEN RUNNING IT ON THE HOT SIDE OF THE DEVICE FOR A CASE AND WHEN IT WAS TIME TO SWITCH IT OVER TO THE COLD SIDE, THE DEVICE STARTED ALARMING. IT WAS THEN THEY NOTICED THE COIL HAD ICED UP AND THE WATER WAS NOT FLOWING." A SECOND DEVICE WAS USED TO FINISH OUT THE CASE, NO CLAIM OF INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12170340 ↗
• MalfunctionJun 28, 2021Filling Problem

  CUSTOMER STATES THAT THIS HEMOTHERM IS CONTINUALLY HAVING ISSUES WITH THE COOL RESERVOIR FILLING WHILE HEATING AND THE HEAT RESERVOIR EMPTYING DURING PROCEDURES.

  Patient problems: Insufficient Information

  MAUDE report 12079577 ↗
• MalfunctionJun 11, 2021Device Emits Odor; Smoking

  CUSTOMER REPORTED THAT THE HEMOTHERM 400 CE HAD AN ISSUE DURING A CASE. "THE HEMOTHERM STARTED TO SMOKE AND FILLED THE CARDIAC OR WITH SMOKE AND A VERY NOXIOUS ODOR. BIOMED SWAPPED OUT THE UNIT AND DETERMINED THAT IT WAS THE POWER SUPPLY BOARD."

  Patient problems: Insufficient Information

  MAUDE report 11985996 ↗
• MalfunctionFeb 24, 2021Insufficient Heating; Failure to Power Up

  DURING SURGERY THE MACHINE HEATED THE WATER TO 42°C, BUT WHEN THE PERFUSIONIST TURNED ON THE PUMP, THE HEATER TURNED OFF AND IT NEVER TURN ON AGAIN. THE TEMPERATURE DROPPED TO 30°C BUT THE SETPOINT WAS IN 42°C. LATER, THEY CHECKED THE MACHINE AND WHEN TURNED ON THE PUMP IN THE HEATER MODE, THE MACHINE DID NOT HEAT THE WATER. BUT IF THEY STOP THE PUMP, THE HEATER STARTED TO HEAT. NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11373254 ↗
• MalfunctionFeb 23, 2021Insufficient Heating

  CUSTOMER STATED THAT DURING A CASE THE HEMOTHERM 400CE STOPPED HEATING. THEY USED ANOTHER HEMOTHERM DEVICE TO FINISH THE CASE. NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11365394 ↗
• MalfunctionDec 29, 2020Pumping Stopped

  CUSTOMER REPORTED, THE PUMP STOPPED WORKING ON THIS DEVICE DURING A PROCEDURE. THE DEVICE WAS SWITCHED OUT WITH ANOTHER HEMOTHERM DEVICE AND THE PROCEDURE CONTINUED WITHOUT ANY ISSUES. NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11089618 ↗
• MalfunctionDec 21, 2020Break; Failure to Pump

  CUSTOMER CALLED IN FROM THE OR WITH THE HEMOTHERM 400CE NOT PUMPING WATER. THE CUSTOMER WAS WALKED THROUGH EVALUATING THE FUSES ON THE POWER SUPPLY BOARD. DURING THE EVALUATION, IT WAS DISCOVERED THE DEVICE HAD A BLOWN 20A FUSE. THE CUSTOMER WAS ABLE TO REPLACE THE FUSE TO CORRECT THE MALFUNCTION AND CONTINUE WITH THE CASE WITHOUT FURTHER INCIDENT. NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11049686 ↗
• MalfunctionNov 25, 2020Insufficient Heating

  THE CUSTOMER REPORTED A HEATING MALFUNCTION OCCURRED, THE DEVICE STOPPED HEATING NEAR THE END OF A SURGICAL CASE. THE DEVICE WAS SET AT 38 DEGREES, REACHED SET TEMP AT START OF CASE BUT THEN DROPPED AND WOULD NOT RISE TO SET POINT. THE CUSTOMER COULD NOT GET THE DEVICE TO HEAT ABOVE 30 DEGREES EVEN THOUGH THE HIGH AND LOW HEATING LED INDICATORS WERE ON. NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10905050 ↗
• MalfunctionNov 5, 2020Temperature Problem

  CUSTOMER STATED THEY HAD THE DEVICE SET TO 36 AND THE SYSTEM WAS MEASURING 41 DEGREES. NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10794516 ↗
• MalfunctionNov 5, 2020Insufficient Cooling

  CUSTOMER REPORTED THEY EXPERIENCED A HEATER COOLER CONCERN ON (B)(6) 2020. PROFUSION NOTED ON THE COOLING FUNCTION THEY HAD SET THE DEVICE TO 36 AND THE SYSTEM WAS MEASURING 41 DEGREES. SINCE THE DEVICE WAS ONLY BEING USED FOR COOLING (AND A DIFFERENT DEVICE WAS BEING USED FOR HEATING), THE HEATING SET POINT (ON THE COOLING DEVICE) WAS LOWERED TO THE LOWEST SETTING TO ALLOW THE PROCEDURE TO CONTINUE RATHER THAN SWAPPING THE DEVICE OUT DURING THE CASE. NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10793084 ↗
• MalfunctionJun 17, 2020Incorrect, Inadequate or Imprecise Result or Readings; Temperature Problem

  THE CUSTOMER STATED THAT THE HEMOTHERM UNIT FAILED, THE TEMPERATURE WOULD NOT GO ABOVE 36°C. THE UNIT WAS SWAPPED OUT. NO ADVERSE EVENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10162989 ↗
• MalfunctionJun 2, 2020Device Displays Incorrect Message; No Flow

  CUSTOMER STATES THAT WHILE ON CARDIOPULMANARY BYPASS (CBP), HEATER COOLER ALARMED AND STOPPED FUNCTIONING. THE RIGHT HAND SIDE OF HEATER COOLER (HEAT SIDE) SHOWED "EE" INSTEAD OF TEMPERATURE, AND WATER WAS NOT FLOWING. USER ATTEMPTED A REBOOT RESULTING IN THE SAME ERROR MESSAGE. WATERLINES WERE QUICKLY CHANGED TO A DIFFERENT COOLER. NO ADVERSE EVENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10110414 ↗
• MalfunctionApr 3, 2020Defective Device; Infusion or Flow Problem

  CUSTOMER REPORTED ISSUE: DURING A PROCEDURE WHILE IN HEATING MODE THE HEAT RESERVOIR BEGAN TO EMPTY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9924829 ↗
• MalfunctionApr 2, 2020Incorrect, Inadequate or Imprecise Result or Readings; Temperature Problem

  DURING A SURGERY, THE HEMOTHERM 400CE SENT THE EE02 ERROR MESSAGE INDICATING A HEAT THERMISTOR DISCREPANCY - REPLACE THERMISTOR. NO PATIENT/USER INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9915397 ↗
• MalfunctionJan 18, 2020Defective Device

  CUSTOMER REPORTED ON (B)(6) 2019 THAT ON (B)(6) 2019 THE HEMOTHERM DEVICE WOULD NOT GO ABOVE 34C. A REPLACEMENT UNIT WAS BROUGHT IN AND WARMING CONTINUED. CUSTOMER REPORTED THAT THERE WAS NO PATIENT HARM BUT THERE WAS A DELAY IN SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9604710 ↗
• MalfunctionJan 18, 2020Temperature Problem

  CUSTOMER REPORTED ON (B)(6) 2019 THAT ON (B)(6) 2019 THE HEMOTHERM DEVICE WOULD NOT GO ABOVE 34C. A REPLACEMENT UNIT WAS BROUGHT IN AND WARMING CONTINUED. CUSTOMER REPORTED THAT THERE WAS NO PATIENT HARM BUT THERE WAS A DELAY IN SURGERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9604709 ↗
• MalfunctionDec 20, 2019Insufficient Heating; Insufficient Heating

  CUSTOMER REPORTED THAT DURING THE REWARMING PORTION OF A PROCEDURE, THE HEMOTHERM DEVICE WOULD NOT HEAT ABOVE 34C. THE UNIT WAS REPLACED AND THE PROCEDURE CONCLUDED WITHOUT INCIDENT. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9506929 ↗
• MalfunctionDec 20, 2019Smoking; Smoking

  DURING A PROCEDURE, THE HEMOTHERM HEATER/COOLER WAS BEING SET TO COOL AND MADE A POPPING NOISE FOLLOWED BY AN ELECTRICAL BURN SMELL. THE UNIT WAS REPLACED AND THE PROCEDURE FINISHED WITH NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9506503 ↗
• MalfunctionDec 18, 2019Insufficient Cooling; Insufficient Cooling

  CUSTOMER REPORTED THE HEMOTHERM STOPPED WORKING DURING A PROCEDURE AND ALARMED WITH THE EE03 ALARM CODE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9491513 ↗
• MalfunctionNov 7, 2019Insufficient Heating; Insufficient Heating

  A HEMOTHERM WILL NOT REACH MAXIMUM TEMPERATURE. ANOTHER HEMOTHERM DEVICE WAS USED TO CONTINUE WITH THE PROCEDURE WITHOUT INCIDENT. CUSTOMER REPORTED THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9290181 ↗
• MalfunctionSep 10, 2019Output Problem

  A CUSTOMER REPORTED THE HEMOTHERM 400CE WENT DOWN DURING A CASE WITH AN EE03 ERROR. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8983417 ↗
• MalfunctionAug 26, 2019Circuit Failure; Circuit Failure

  CUSTOMER STATED THAT HEMOTHERM 400CE UNIT STOPPED PUMPING WATER DURING A CASE. F6 FUSE WAS BLOWN ON THE POWER BOARD. NO ADVERSE EVENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8932311 ↗
• MalfunctionAug 9, 2019Insufficient Heating; Insufficient Heating

  USER REPORTED THE HEMOTHERM 400CE HEATER-COOLER WAS HEATING SLOWLY. THE UNIT WOULD NOT HEAT OVER 29C. NO ADVERSE EVENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8881214 ↗