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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 Electrical /Electronic Property Problem (1198); Temperature Problem (3022)
Patient Problem No Patient Involvement (2645)
Event Date 10/15/2020
Event Type  Malfunction  
Manufacturer Narrative

The hcu 30 showed the error '5004-2' and '1004-2'. According to the describe event or problem grid the field service technician (fst) reconnected the connections on the control board and power supply board. The fst adjusted the mains side actuator. All function tests passed. The most probable root cause for the failure '5004-2' were loose connections on the control board or power supply board. The most probable root cause for the failure '1004-2' were wrong setting of the 3-way valve (actuator). Thus the reported failures '5004-2 and 1004-2' can be confirmed. The failures occurred during start up of the device. The hcu 30 which was used, was responsible for this complaint. The occurrence rate was calculated for the reported issue, and it was determined that this is not a systemic issue. Therefore, no remedial action is required. The occurrence rate related to the reported issue is currently being monitored as part of maquet cardiopulmonary¿s trending program, additional investigations, or corrections will be implemented in case of adverse trending.

 
Event Description

It was reported that the hcu 30 showed the error ¿5004-2- control a/d reference resistor/ad error¿ and ¿1004-2 main heater temp. Sensor error¿ during start up of the device. Complaint#: (b)(4).

 
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Brand NameHEATER COOLER UNIT
Type of DeviceCONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
MAQUET CARDIOPULMONARY GMBH
neue rottenburger strasse 37
hechingen
Manufacturer (Section G)
NURSEL BOELENS
maquet cardiopulmonary ag
kehler strasse 31
rastatt 76437
GM 76437
Manufacturer Contact
maquet cardiopulmonary ag
kehler strasse 31
rastatt 76437
4972229321
MDR Report Key10725608
MDR Text Key212743264
Report Number8010762-2020-00353
Device Sequence Number1
Product Code DWC
Combination Product (Y/N)N
Reporter Country CodeIN
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 10/23/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/23/2020
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? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/15/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/07/2013
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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