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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 06/07/2021
Event Type  Malfunction  
Manufacturer Narrative

The investigation is ongoing. A follow up medwatch will be submitted when new information becomes available.

 
Event Description

The temperature of the main side circuit of hcu30 stopped rising. Although the unit was in clinical use, it was replaced with another heater cooler unit and the operation was continued, so there was no effect on 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
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MDR Report Key12016574
MDR Text Key256721886
Report Number8010762-2021-00354
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 06/17/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/17/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberHCU 30
Device Catalogue Number701034642
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 Received06/07/2021
Was Device Evaluated By Manufacturer? No
Date Device Manufactured09/16/2017
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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