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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY ROTOFLOW DRIVER; ECMO PUMP
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MAQUET CARDIOPULMONARY ROTOFLOW DRIVER; ECMO PUMP Back to Search Results
Device Problems Failure to Zero (1683); Device Displays Incorrect Message (2591)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/18/2017
Event Type  Injury  
Event Description
Per ecmo specialist: at 15:40 persistent sig error on pump driver.Assisted by 2 staff members, pt was clamped out, paste applied, attempted to rezero driver, and driver would not rezero after 3 attempts.Rotoflow placed on hand crank while pump had and driver changed out.Once new pump head and driver were in place, pt clamped out again, rotoflow switched from hand crank to pump head, driver were in place, pt clamped out again, rotoflow switched from hand crank to pump head, driver successfully zeroed, pt unclamped and forward flow reestablished at previous rpms.Physician present during the event and equipment change out.Perfusion notified.Pt back on at 15:55.Pt received bagging during event.No compressions.
 
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Brand Name
ROTOFLOW DRIVER
Type of Device
ECMO PUMP
Manufacturer (Section D)
MAQUET CARDIOPULMONARY
kehler str. 31
rastatt
GM 
MDR Report Key6670348
MDR Text Key78566647
Report Number6670348
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 06/21/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/26/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/21/2017
Distributor Facility Aware Date06/19/2017
Event Location Hospital
Date Report to Manufacturer06/21/2017
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Life Threatening;
Patient Age6 YR
Patient Weight7
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