BEUDAMED
    FDA Adverse Event Death Summary report: N

    SRD SCPC LEVEL BUBBLE

    MDR report key: 2161128 · Received July 6, 2011

    Report

    Report Number
    1718850-2011-00064
    Event Type
    Death
    Date Received
    July 6, 2011
    Date of Event
    May 24, 2011
    Report Date
    June 6, 2011
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    DTQ
    PMA / PMN Number
    K020571
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE STOCKERT CENTRIFUGAL PUMP CONSOLE. THE INCIDENT OCCURRED AT (B)(6) HOSPITAL IN (B)(6). THIS MEDWATCH IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP (B)(4) RECEIVED A REPORT THAT THE FLOW RATE OF THE SCPC DID NOT DISPLAY CORRECTLY. THE SYSTEM HAS BEEN RETURNED BY THE CUSTOMER TO SORIN GROUP (B)(4) FOR EVALUATION. THE INVESTIGATION IS ON GOING. A FOLLOW UP REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETED. THE CUSTOMER REPORTED THAT THE PATIENT WAS HIGH RISK AND THAT THE FACILITY FELT THAT THERE WAS "NO RELATION BETWEEN THE MALFUNCTION AND THE PATIENT'S DEATH." HOWEVER, THE FACILITY WILL REPORT THIS EVENT TO THE COMPETENT AUTHORITY. THE SYSTEM USED CONSISTED OF A JMFP PUMP AND STOCKERT SCPC. THE JMFP PUMP IS NOT AVAILABLE IN THE USA, BUT THE SCPC TO WHICH IT WAS CONNECTED IS DISTRIBUTED IN THE UNITED STATES. THIS MEDWATCH REPORT IS BEING FILED AS A RESULT OF THESE ISSUES.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) RECEIVED A REPORT THAT THE FLOW RATE OF THE SCPC DID NOT DISPLAY CORRECTLY. THE PATIENT ON THE SYSTEM EXPIRED ON (B)(6) 2011. THE CUSTOMER REPORTED THAT THE PATIENT WAS HIGH RISK AND THAT THE FACILITY FELT THAT THERE WAS "NO RELATION BETWEEN THE MALFUNCTION AND THE PATIENT'S DEATH."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SRD SCPC LEVEL BUBBLE CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ SORIN GROUP DEUTSCHLAND 60-03-75 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death