BEUDAMED
    FDA Adverse Event Other Summary report: N

    STOCKERT CENTRIFUGAL PUMP CONSOLE

    MDR report key: 2860251 · Received November 26, 2012

    Report

    Report Number
    1718850-2012-01061
    Event Type
    Other
    Date Received
    November 26, 2012
    Date of Event
    September 17, 2012
    Report Date
    October 30, 2012
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    DTQ
    PMA / PMN Number
    K020571
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE STOCKERT CENTRIFUGAL PUMP CONSOLE. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP RECEIVED A REPORT THAT DURING A PROCEDURE, THE STOCKERT CENTRIFUGAL PUMP CONSOLE HAD A UPS ISSUE AND AN ERROR CODE WAS DISPLAYED. THERE WAS NO REPORT OF PT INJURY. A SORIN GROUP FIELD SERVICE TECHNICIAN WAS DISPATCHED TO THE FACILITY TO EVALUATE THE ISSUE. THE UNIT WAS TESTED AND THE REPORTED ISSUE COULD NOT BE REPRODUCED. AS A PRECAUTIONARY ACTION, THE BATTERIES OF THE PUMP CONSOLE WERE REPLACED. THE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP RECEIVED A REPORT THAT DURING A PROCEDURE, THE STOCKERT CENTRIFUGAL PUMP CONSOLE HAD A UPS ISSUE AND AN ERROR CODE WAS DISPLAYED. THERE WAS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STOCKERT CENTRIFUGAL PUMP CONSOLE PUMP, BLOOD, CARIOPULMONARY BYPASS, NON-ROLLER TYPE DTQ SORIN GROUP DEUTSCHLAND 60-03-75 NA

    Patients

    Seq Age Sex Outcome Treatment
    1