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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH HEATER COOLER UNIT MAQUET HCU 30 CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

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MAQUET CARDIOPULMONARY GMBH HEATER COOLER UNIT MAQUET HCU 30 CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 701034642 - HCU 30
Device Problems Insufficient Heating (1287); Temperature Problem (3022)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/13/2020
Event Type  malfunction  
Manufacturer Narrative
During surgery, the error message when raise the temperature occurred. The perfusionist reported that the hcu 30 showed the error message "3004: cardiac protection side temperature error" when raise the temperature during surgery. After restart of the device no error occurred and the surgery could be continued. There was no harm to the patient. According to the service report #(b)(4) dated 2020-03-17 the getinge field service technician (fst) was onside and checked the device. The error could not be reproduced during repair and no parts had to be replaced. According to the service report the most probable root cause could be a shortage of water in the tank. Additional water was injected into the tank, after which the device could be used normally again. Function tests passed and the device is already back in use. Thus the reported error message when raise the temperature could not be confirmed. The reported failure happened during surgery. The hcu 30 which was used, was responsible for this complaint. The occurence rate regarding the above complaint is below the acceptance rate. Thus, no remedial action required. 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
(b)(4). It was reported that the heater cooler unit hcu 30 displayed the error message "3004" during surgery, while trying to raise the temperature. When restarting the device the error did not occur again. No health problem for patients occurred.
 
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Brand NameHEATER COOLER UNIT MAQUET HCU 30
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 Key9859029
MDR Text Key199231137
Report Number8010762-2020-00112
Device Sequence Number1
Product Code DWC
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K031554
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation
Type of Report Initial
Report Date 03/18/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/20/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number701034642 - HCU 30
Device Catalogue Number701034642
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/17/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/21/2009
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Reuse

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