BEUDAMED
    FDA Adverse Event Other Summary report: N

    SENSOR MODULE LEVEL/BUBBLE

    MDR report key: 2576165 · Received May 11, 2012

    Report

    Report Number
    1718850-2012-00057
    Event Type
    Other
    Date Received
    May 11, 2012
    Date of Event
    April 9, 2012
    Report Date
    April 11, 2012
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    DTW
    PMA / PMN Number
    K955152
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MFRS THE SENSOR MODULE LEVEL/BUBBLE. THE LEVEL SENSOR CONNECTS TO THE MODULE AND THE 510(K) IS K955152. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP USA RECEIVED A REPORT FROM A CUSTOMER THAT THEY HAD TWO LEVEL SENSORS THAT WERE NOT WORKING PROPERLY. THERE WAS NO PT INVOLVEMENT. A SORIN GROUP USA FIELD SERVICE REP WAS DISPATCHED TO EVALUATE THE ISSUE. THE FIELD REP TESTED THE LEVEL SENSOR AND FOUND THAT THE SENSOR ALWAYS READ FULL, EVEN WITHOUT THE LEVEL SENSOR PAD CONNECTED. THE LEVEL SENSOR AND MODULE WERE REPLACED, WHICH RESOLVED THE ISSUE. THE LEVEL SENSORS AND THE MODULE ARE BEING RETURNED FOR EVAL. THE INVESTIGATION IS ONGOING. A F/U REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP USA RECEIVED A REPORT FROM A CUSTOMER THAT THEY HAD TWO LEVEL SENSORS THAT WERE NOT WORKING PROPERLY. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSOR MODULE LEVEL/BUBBLE MONITOR AND/OR CONTROL, LEVEL SENSING, CARDIOPULMONARY BYPASS DTW SORIN GROUP DEUTSCHLAND 23-30-20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1