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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 Insufficient Heating (1287)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/12/2021
Event Type  Malfunction  
Manufacturer Narrative

A follow-up medwatch will be submitted when additional information becomes available. Further information has been requested but has not yet been received.

 
Event Description

It was reported that the hcu 30 showed the error ¿1004-0 main heater temp. Sensor error¿. The failure occurred during patient treatment and the device has been exchanged with a backup device. This error may lead to a heating malfunction. Complaint id: (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
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MDR Report Key12165661
MDR Text Key261447272
Report Number8010762-2021-00392
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,Followup
Report Date 07/27/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/14/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberHCU 30
Device Catalogue Number701028718U
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 Received07/23/2021
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/16/2017
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 07/14/2021 Patient Sequence Number: 1
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