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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG MAQUET HCU40 CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

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MAQUET CARDIOPULMONARY AG MAQUET HCU40 CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS Back to Search Results
Model Number HEATER-COOLER UNIT
Device Problem Microbial Contamination of Device (2303)
Patient Problem No Patient Involvement (2645)
Event Date 04/04/2017
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Maquet is developing new hygiene protocols for its heater-cooler units hcu 40, hcu 30 and hcu 20. These new protocols include preventive measures, routine disinfection as well as high level disinfection and biofilm reduction ¿ also effective against atypical mycobacteria in the water systems. The newly developed disinfection procedures are taking a holistic approach based on validated methods. The timeline for the introduction of the new hygiene protocols is being examined in order to communicate reliable dates as requested by health authorities. A supplemental medwatch will be submitted when new information has been received.

 
Event Description

It was reported that the hcu40 was contaminated with mycobacteria. The water samples were taken during service, so there was no patient involved or could be harmed. (b)(4).

 
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Brand NameMAQUET HCU40
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 Key6526041
MDR Text Key74042258
Report Number8010762-2017-00133
Device Sequence Number1
Product Code DWC
Combination Product (Y/N)N
Reporter Country CodeUK
PMA/PMN NumberK130300
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 08/18/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/27/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberHEATER-COOLER UNIT
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 Received04/04/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/01/2016
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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