• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MAQUET CARDIOPULMONARY AG MAQUET HCU40 DEVICE CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 701044054
Device Problem Contamination of Device Ingredient or Reagent (2901)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/15/2016
Event Type  Malfunction  
Manufacturer Narrative

(b)(6) 2016 11:49 am (gmt-5:00) added by (b)(6) ((b)(4)): maquet medical systems, usa submits this report on behalf of the legal manufacturer of the device maquet (b)(4). On (b)(4) 2015, a fsca was issued regarding revised decontamination procedures for heater and heater-cooler systems from maquet. Since the issuance of the (b)(4) 2015 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 (b)(4) 2015 fsca on hold pending a resolution of this issue. As soon as the dates are known for implementing the fsca a supplemental medwatch will be submitted.

 
Event Description

(b)(6) 2016 11:41 am (gmt-5:00) added by (b)(6) ((b)(4)): the hospital took water samples after the installation of the units, and a value of > 100kbe (colony forming units) in all 3 hcu40 units was detected. The following 3 microorganism strains with a accuracy of score > 2 (=2 means "unique detection") were detected: -pseudo. Pseudoalcaligenes -pseudo. Alcaliphila -staph. Epidermitis. It was also ensured that the contamination did not originate from the water-tap. This suspicion could not be confirmed. Please note that 2 further complaints for the other mentioned devices were created with the following complaint numbers: (b)(4). (b)(4).

 
Manufacturer Narrative

On 2015-11-30, 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. December 2016 is the scheduled market launch of this new disinfection procedure.

 
Event Description

(b)(4).

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
GM
Manufacturer Contact
maquet cardiopulmonary ag
kehler strasse 31
76437 rastatt 
4972229321
MDR Report Key5495588
MDR Text Key40594485
Report Number8010762-2016-00166
Device Sequence Number1
Product Code DWC
Combination Product (Y/N)N
Reporter Country CodeSZ
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
Type of Report Initial,Followup
Report Date 02/15/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/11/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number701044054
Device Catalogue Number701044054
Was Device Available For Evaluation? No Answer Provided
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
Date Device Manufactured12/01/2015
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-