BEUDAMED
    FDA Adverse Event Other Summary report: N

    SCP PANEL CENTRIFUGE JMS

    MDR report key: 3690797 · Received March 14, 2014

    Report

    Report Number
    1718850-2014-00061
    Event Type
    Other
    Date Received
    March 14, 2014
    Date of Event
    February 13, 2014
    Report Date
    February 17, 2014
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    DWA
    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 SCP PANEL CENTRIFUGE JMS. THIS DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES BUT IS SIMILAR TO THE 60-02-15 STOCKERT CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP WHICH IS DISTRIBUTED IN THE UNITED STATES. THE 510K NUMBER FOR THE STOCKERT CENTRIFUGAL PUMP SYSTEM IS K032213. THE INCIDENT OCCURRED IN (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 ALL OF LEADS ON THE SCP PANEL CENTRIFUGE CAME ON AND THE PUMP STOPPED DURING A PROCEDURE. THE CLINICIAN POWERED THE SYSTEM OFF THEN ON AND FUNCTIONALITY WAS RESTORED. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT. THERE WAS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152159 SCP PANEL CENTRIFUGE JMS PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE DWA SORIN GROUP DEUTSCHLAND 60-02-20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1