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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 701044054
Device Problems Alarm Not Visible (1022); Loss of Power (1475); Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/15/2016
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). A maquet field service technician was on site and investigated the unit. The technician troubleshot the device and found a defective flow sensor. The flow sensor was replaced and the unit was tested for functionality successfully. A supplemental medwatch will be submitted if additional informations becomes available.

 
Event Description

According to the customer: hcu40 gives cardio / patient side flow low alarm and stops the pump after de-airing completes. Additional information: the incident occurred during patient treatment, there were no negative consequences for the patient or a delay in surgery / therapy. (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
GM
Manufacturer Contact
maquet cardiopulmonary ag
kehler strasse 31
76437 rastatt 
4972229321
MDR Report Key5888506
MDR Text Key53493448
Report Number8010762-2016-00524
Device Sequence Number1
Product Code DWC
Combination Product (Y/N)N
Reporter Country CodeMY
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
Report Date 07/25/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/19/2016
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? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/25/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/01/2015
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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