BEUDAMED
    FDA Adverse Event Other Summary report: N

    STOCKERT CENTRIFUGAL PUMP CONSOLE

    MDR report key: 3894220 · Received June 17, 2014

    Report

    Report Number
    1718850-2014-00213
    Event Type
    Other
    Date Received
    June 17, 2014
    Date of Event
    March 11, 2014
    Report Date
    June 16, 2014
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    DTQ
    PMA / PMN Number
    K020571
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURERS THE STOCKERT CENTRIFUGAL PUMP CONSOLE (SCPC). THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS FILLED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP RECEIVED A REPORT THAT DURING SET-UP, THE STOCKERT CENTRIFUGAL PUMP CONSOLE (SCPC) WOULD NOT PASS THE BATTERY TEST AND THAT THE CENTRIFUGAL PUMP WAS GETTING AN ERROR. THERE WAS NO PATIENT INVOLVEMENT. THE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP RECEIVED A REPORT THAT DURING SET-UP, THE STOCKERT CENTRIFUGAL PUMP CONSOLE (SCPC) WOULD NOT PASS THE BATTERY TEST AND THAT THE CENTRIFUGAL PUMP WAS GETTING AN ERROR. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355770 STOCKERT CENTRIFUGAL PUMP CONSOLE PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE DTQ SORIN GROUP DEUTSCHLAND 60-30-00 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NP