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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY MAQUET ROTOFLOW/CONSOLE; ECMO CENTRIFUGAL PUMP
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MAQUET CARDIOPULMONARY MAQUET ROTOFLOW/CONSOLE; ECMO CENTRIFUGAL PUMP Back to Search Results
Model Number 70105.1712
Device Problems Device Emits Odor (1425); Failure to Pump (1502); Device Displays Incorrect Message (2591)
Patient Problem Cardiopulmonary Arrest (1765)
Event Date 01/04/2017
Event Type  Injury  
Event Description
Ecmo pump/console malfunction.Alarm from rotoflow console, accompanied by profound "burning" smell.Pt immediately clamped out, staff assist called, rotoflow head switched to hand crank.Once hand cranking established, pt unclamped to reestablish forward flow.Rotoflow pump and console switched out.Rotoflow head switched from hand crank back to pump.Console reset and zeroed, rpm's up.Pt then unclamped, ecmo flow reestablished.Pt experienced a brief code with 1 min of cpr given when ecmo pump failed.
 
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Brand Name
MAQUET ROTOFLOW/CONSOLE
Type of Device
ECMO CENTRIFUGAL PUMP
Manufacturer (Section D)
MAQUET CARDIOPULMONARY
kehler str. 31
rastatt 76437
GM  76437
MDR Report Key6251492
MDR Text Key65024311
Report Number6251492
Device Sequence Number1
Product Code KFM
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/06/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/06/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number70105.1712
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/06/2017
Distributor Facility Aware Date01/04/2017
Event Location Hospital
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Life Threatening; Required Intervention;
Patient Age13 YR
Patient Weight32
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