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U.S. Department of Health and Human Services

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

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MAQUET CARDIOPULMONARY AG MAQUET HCU40 DEVICE CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 70104.4054
Device Problem Microbial Contamination of Device (2303)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Malfunction  
Manufacturer Narrative

(b)(6) 2015 02:34 pm (gmt-4:00) added by (b)(6) ((b)(4)): maquet cardiopulmonary have not yet received any lab results which confirm the bacterial contamination. This issue is under further investigation with regard to capa (b)(4). A supplemental medwatch will be submitted as soon as additional information becomes available. (b)(4).

 
Event Description

(b)(6) hospital have had some water samples analysed from the hcu's (2x 40's and 1x 30) and have had a positive result for mycobacterium from one of the samples. They have not as far as we are aware tested the tap water but have now added a bacterial water filter to the tap used to fill the heater coolers. Further samples are away for culture at the moment. They have been following the ifu to the letter up to this point and this sample was taken just before the scheduled cleaning process.

 
Manufacturer Narrative

(b)(4). Further information has not been forthcoming from the customer. A questionnaire was sent to the customer on 2015-07-23. They have not completed the form or specified which of the two hcu40s were the source of the results. The have at present not released any lab findings. No decontamination report was provided for this unit. On 2015-11-30, a fsca was issued regarding revised decontamination procedures for heater and heater-cooler systems from maquet. Since the issuance of the 2015-11-30 fsca, maquet has become aware of the possibility that the rinsing process for the high level disinfection with 5% chloramine-t may not adequately remove all residual disinfectant. Therefore maquet is putting the 2015-11-30 fsca on hold pending a resolution of this issue. In order to ensure the highest possible patient safety, maquet has decided to perform a further validation to ensure safety factors are challenged by the disinfection processes delineated in the corresponding ifus. This additional validation will challenge the disinfection process with real world, highly contaminated devices representing the worst case possible. This validation will be performed and completed: in january 2016 for hcu 40. In february 2016 for hcu 30 & hu 35. In march 2016 for hcu 20. A supplemental medwatch will be submitted as soon as additional information are available.

 
Event Description

No patient injuries have been connected with this report. (b)(4).

 
Manufacturer Narrative

On nov 30,2015, fsca 2015-11-30 was issued regarding revised decontamination procedures for heater and heater-cooler systems from maquet. This fsca was put on hold a few days later with fsca 2015-12-10. A new fsca will be issued as soon as the new disinfection procedure is properly validated and can be launched. The new ifu is currently under revision and will contain the instructions for the new disinfection procedure. Market launch of the new disinfection procedure is december 2016.

 
Event Description

(b)(4).

 
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Brand NameMAQUET HCU40 DEVICE
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 76437
GM 76437
Manufacturer Contact
maquet cardiopulmonary ag
kehler strasse 31
76437 rastatt 76437
4972229321
MDR Report Key5019226
MDR Text Key24660006
Report Number8010762-2015-01006
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 CONSUMER,FOREIGN,HEALTH PROFE
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Remedial Action Other
Type of Report Initial,Followup,Followup
Report Date 07/22/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/20/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number70104.4054
Device Catalogue Number70104.4054
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/29/2016
Was Device Evaluated By Manufacturer? No Answer Provided
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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