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U.S. Department of Health and Human Services

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

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MAQUET CARDIOPULMONARY GMBH HEATER COOLER UNIT 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 04/16/2020
Event Type  malfunction  
Manufacturer Narrative
During treatment, the failure " alarm 1004-2 and 3004-2 (heater temp. )" occurred. The alarm on the hcu 30 occurred during clinical use, the content of the alarm was unknown. After restarting the device the failure did not return and clinical use was successfully completed during normal operation. According to the service report #43318155 dated 2020-04-16 the getinge field service technician (fst) replaced the magnet valve 24 vac e121k4503 (material #70103. 4032) after checking the error log. As a result of log extraction, the error of 1004-2 / 4 and 3004-2 / 4 could be confirmed. The error codes occurred when the temperature did not reach the specified temperature. The error was most probably caused by insufficiently circulating water. The failure could not be reproduced. Each valve was disassembled and cleaned, and it was found that the shunt valve on the myocardial side was damaged due to aging. After replacing the shunt valve, function tests all passed. The most probable cause was a damaged shunt valve due to aging. Thus the reported failure " alarm 1004-2 and 3004-2 (heater temp. )" " could be confirmed. The reported failure happened during treatment. 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 and additional investigations or corrections will be implemented in case of adverse trending.
 
Event Description
Complaint #(b)(4). The alarm "error 1004-2 / 4 and error 3004-2 / 4" on the hcu 30 occurred during clinical use. After restarting the device the failure did not return and clinical use was successfully completed during normal operation.
 
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Brand NameHEATER COOLER UNIT 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 Key9983966
MDR Text Key198729415
Report Number8010762-2020-00134
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
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/21/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/21/2020
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? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/16/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/20/2010
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Reuse

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