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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
Model Number 701044054
Device Problems Insufficient Flow or Under Infusion (2182); Device Displays Incorrect Message (2591)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). A follow-up medwatch will be submitted when additional information becomes available.

 
Event Description

It was reported that the hcu 40 had a low flow error on the cardioplegia side. This incident occurred on start up of the device. (b)(4).

 
Manufacturer Narrative

(b)(4). The initial medwatch, which was sent to the fda, was incorrectly evaluated to be reportable. The reported issue was incorrectly assessed to be "pat. Water pressure too high". This is reportable, however, the correct assessment should have been "leakage at the bottom of the device" which is not reportable. This reported issue is also a continuation of a previous complaint which was not reportable. During the investigation, the origin of the leakage was identified. The relevant parts were replaced and the device was deemed fit for purpose. This follow up medwatch was generated to inform the fda that the initial medwatch was raised in error. This follow up report also serves as a final notification to this issue.

 
Event Description

(b)(4).

 
Search Alerts/Recalls

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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 Key6083393
MDR Text Key59605653
Report Number8010762-2016-00660
Device Sequence Number1
Product Code DWC
Combination Product (Y/N)N
Reporter Country CodeAS
PMA/PMN NumberK130300
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/29/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/07/2016
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? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/17/2016
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured05/01/2015
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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