BEUDAMED
    FDA Adverse Event Other Summary report: N

    STOCKERT CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP

    MDR report key: 2957223 · Received January 31, 2013

    Report

    Report Number
    1718850-2013-00004
    Event Type
    Other
    Date Received
    January 31, 2013
    Date of Event
    January 4, 2013
    Report Date
    January 4, 2013
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    JPZ
    PMA / PMN Number
    K030013
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE STOCKERT CENTRIFUGAL PUMP SYSTEM. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS FILED ON BEHALF OF SORIN GROUP (B)(4). A SORIN GROUP FIELD SVC REP WAS DISPATCHED TO INVESTIGATE. WHILE AT THE FACILITY THE SVC REP REPLACED THE CPU BOARD AND SUBSEQUENT TESTING CONFIRMED THAT THE ISSUE WAS RESOLVED. THE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP REC'D A REPORT THAT THE SCP DISPLAYED AN ERROR CODE DURING PRIMING. THERE WAS NO PT INVOLVEMENT AS THE ISSUE OCCURRED DURING PRIMING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41908 STOCKERT CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS JPZ SORIN GROUP DEUTSCHLAND 60-02-15 NA

    Patients

    Seq Age Sex Outcome Treatment
    1