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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 Problems Excessive Cooling (2932); Temperature Problem (3022)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/13/2021
Event Type  Malfunction  
Manufacturer Narrative

It was reported that the hcu 30 builds too much ice, during patient treatment. The getinge field service technician (fst) was sent for investigation on 2021-04-13. The fst confirmed the failure. The ice sensor kit (material #70103. 4528) was replaced. All function test passed. Ice sensor kit (material 70103. 4528) was already investigated in a similar complaint in the getinge life cycle engineering, on 2020-04-16. The investigated ice sensor was damaged through corrosion. Electrical resistances for two out of three ntcs (negative temperature coefficient thermistor) showed readings significantly off specifications. The most probably root caused was corrosion that caused the negative temperature coefficient to show reading off specifications. Therefore, the most probable root cause for ice overbuild is a defective ice sensor due to corrosion. The product in question was produced in 2012-05-31. The review of the non-conformities during the period of 2012-05-31 to 2021-04-27 does not show any non-conformity in regard to the reported product and failure. There is no indication that manufacturing issues occurred during this time, thus production related influences can be excluded. The reported failure can be confirmed. The occurrence rate related to the reported issue is currently being monitored as part of maquet cardiopulmonary´s trending program and additional investigations or corrections will be implemented in case of adverse trending.

 
Event Description

Complaint number #: (b)(4). It was reported that the hcu 30 builds too much ice.

 
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Brand NameHEATER COOLER UNIT
Type of DeviceCONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
MAQUET CARDIOPULMONARY GMBH
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hechingen
Manufacturer (Section G)
JULIA KAPFENBERGER
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hechingen
Manufacturer Contact
neue rottenburger strasse 37
hechingen 
MDR Report Key11775879
MDR Text Key249057211
Report Number8010762-2021-00285
Device Sequence Number1
Product Code DWC
Combination Product (Y/N)N
Reporter Country CodeRS
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 05/05/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/05/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberHCU 30
Device Catalogue Number70103.4642
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/13/2021
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/31/2012
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Reuse

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