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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH HEATER COOLER UNIT CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

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MAQUET CARDIOPULMONARY GMBH HEATER COOLER UNIT CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS Back to Search Results
Model Number HCU 30
Device Problem Excessive Heating (4030)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/03/2021
Event Type  Malfunction  
Manufacturer Narrative

It was reported that the hcu 30 could not lower the temperature of the circulating water on the main side, and ice melted. The failure occurred during patient treatment. No indication of actual or potential for harm or death. A getinge field service technician (fst) will be sent for investigation. A follow up medwatch will be submitted when new information becomes available.

 
Event Description

The temperature of the circulating water on the main side became difficult to lower during surgery. The temperature drop on the cardioplegia side did not seem to be a problem. The chunks of ice in the tank had melted, especially on the main side. The surgery was replaced with another hcu30 and continued. Therefore, there was no problem with the surgery and the patient. Complaint#(b)(4).

 
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Brand NameHEATER COOLER UNIT
Type of DeviceCONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
MAQUET CARDIOPULMONARY GMBH
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Manufacturer (Section G)
JULIA KAPFENBERGER
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Manufacturer Contact
neue rottenburger strasse 37
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MDR Report Key12317576
MDR Text Key266365816
Report Number8010762-2021-00445
Device Sequence Number1
Product Code DWC
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK031544
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,FOREIGN,HEALTH PROFE
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 08/13/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/13/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberHCU 30
Device Catalogue Number70103.4642
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/04/2021
Was Device Evaluated By Manufacturer? No
Date Device Manufactured02/03/2009
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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