BEUDAMED
    FDA Adverse Event Other Summary report: N

    STOCKERT CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP

    MDR report key: 3800547 · Received April 28, 2014

    Report

    Report Number
    1718850-2014-00130
    Event Type
    Other
    Date Received
    April 28, 2014
    Date of Event
    March 29, 2014
    Report Date
    April 1, 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
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP (B)(4) REC'D A REPORT THAT THE FLOW KNOB OF THE STOCKERT CENTRIFUGAL PUMP DID NOT ROTATE SMOOTHLY AND THE OPERATOR HAD DIFFICULTY CONTROLLING THE SPEED. THERE WAS NO REPORT OF PT INJURY. THE INVESTIGATION IS ONGOING. A F/U REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) REC'D A REPORT THAT THE FLOW KNOB OF THE CENTRIFUGAL PUMP DID NOT ROTATE SMOOTHLY AND THE OPERATOR HAD DIFFICULTY CONTROLLING THE SPEED. THERE WAS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253962 STOCKERT CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS DWA SORIN GROUP DEUTSCHLAND 60-02-50 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NP