BEUDAMED
    FDA Adverse Event Other Summary report: N

    STOCKERT CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP

    MDR report key: 4340618 · Received December 5, 2014

    Report

    Report Number
    1718850-2014-00464
    Event Type
    Other
    Date Received
    December 5, 2014
    Date of Event
    October 30, 2014
    Report Date
    November 10, 2014
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    DWA
    PMA / PMN Number
    K032213
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP. THE INCIDENT OCCURRED (B)(6). THIS MEDWATCH REPORT IS FILED ON BEHALF OF SORIN GROUP (B)(4). THE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) RECEIVED A REPORT THAT THE DISPOSABLE PUMP HEAD DISCONNECTED FROM THE CENTRIFUGAL PUMP DRIVER DURING SET UP. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786144 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 NA