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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG MAQUET HCU 40 CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

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MAQUET CARDIOPULMONARY AG MAQUET HCU 40 CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS Back to Search Results
Catalog Number 701044054
Device Problem Contamination (1120)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/14/2017
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). According to laboratory tests the hcu40 was positively tested for mycobacteria. Thus the failure could be confirmed. As mentioned in the instruction for use, the device has to be cleaned with a 5% chloramine-t concentration in the entire water volume of the hcu 40 for special, highly effective disinfection and biofilm removal. The chloramine-t solution must be allowed to act for 24 hours. As stated by email, laboratory tests, performed one month after, came back clean for this device. This reported incident was identified as an issue relating to the decontamination procedures for the device. Capa (b)(4) was opened to address the reported issue. A health hazard evaluation (hhe) was performed to determine the risk associated with the reported issue and the outcome was determined to be low. However, fsca 2015-11-30 was initiated to address the cleaning and decontamination process within the ifu of the hcu40 device. This procedural update was completed on 29 november 2016.

 
Event Description

It was stated that the hcu40 was positively tested for mycobacteria. No patient injury/harm reported. (b)(4).

 
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Brand NameMAQUET HCU 40
Type of DeviceCONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
MAQUET CARDIOPULMONARY AG
rastatt
GM
Manufacturer (Section G)
BERND RAKOW
maquet cardiopulmonary ag
kehler strasse 31
76437 rastatt
GM
Manufacturer Contact
maquet cardiopulmonary ag
kehler strasse 31
76437 rastatt 
4972229321
MDR Report Key7209722
MDR Text Key98052839
Report Number8010762-2018-00030
Device Sequence Number1
Product Code DWC
Combination Product (Y/N)N
PMA/PMN NumberK130300
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,U
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 01/22/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/22/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number701044054
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 Received01/09/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/01/2017
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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