BEUDAMED
    FDA Adverse Event Other Summary report: N

    STOCKERT CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP

    MDR report key: 2820877 · Received October 30, 2012

    Report

    Report Number
    1718850-2012-01029
    Event Type
    Other
    Date Received
    October 30, 2012
    Date of Event
    October 2, 2012
    Report Date
    October 2, 2012
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    DWA
    PMA / PMN Number
    K032213
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO PATIENT INVOLVEMENT. SORIN GROUP (B)(4) MANUFACTURES THE CENTRIFUGAL PUMP. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP RECEIVED A REPORT THAT WHILE SCP SYSTEM WAS BEING TESTED ON A CIRCUIT, ERROR MESSAGES WERE DISPLAYED AND THE RPM'S WERE NOT STABLE. THERE WAS NO PATIENT INVOLVEMENT. THE INVESTIGATION IS ON-GOING. A FOLLOW UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP RECEIVED A REPORT THAT WHILE THE SCP SYSTEM WAS BEING TESTED ON A CIRCUIT, ERROR MESSAGES WERE DISPLAYED AND THE RPM'S WERE NOT STABLE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STOCKERT CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS DWA SORIN GROUP DEUTSCHLAND 60-01-00 NA

    Patients

    Seq Age Sex Outcome Treatment
    1