BEUDAMED
    FDA Adverse Event Other Summary report: N

    STOCKERT S3 LEVEL SENSOR MOUNTING PADS

    MDR report key: 2418299 · Received January 6, 2012

    Report

    Report Number
    1718850-2011-00283
    Event Type
    Other
    Date Received
    January 6, 2012
    Date of Event
    September 1, 2010
    Report Date
    August 26, 2011
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    DTW
    PMA / PMN Number
    K955152
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO LOT NUMBER WAS PROVIDED. THEREFORE, THE MANUFACTURE DATE IS UNK. SORIN GROUP (B)(4) MANUFACTURES THE DISPOSABLE MOUNTING PADS. THE PADS ARE USED WITH THE S3 LEVEL SENSOR, 510(K) NUMBER K955152. THE INCIDENT OCCURRED AT (B)(6). THIS MEDWATCH REPORT IS FILED ON BEHALF OF SORIN GROUP (B)(4). PLEASE NOTE THAT THIS MDR IS BEING FILED LATE DUE TO A RECENT CHANGE IN SORIN GROUP (B)(4) MEDWATCH REPORTING CRITERIA AND SUBSEQUENT REVIEW OF PAST COMPLAINTS TO THE NEW CRITERIA. SORIN GROUP USA RECEIVED A COMPLAINT REPORTING TWO OCCASIONS WHERE, WHEN THE BLOOD LEVEL DROPPED BELOW THE LEVEL SENSOR, THE SENSOR WAS TRIGGERED, BUT NO ALARM WAS PRODUCED AND THE ERC WAS NOT ACTIVATED. THERE WAS NO REPORT OF PT INVOLVEMENT. IT WAS REPORTED THAT THE FUNCTION OF THE SENSOR WAS TESTED FOR FUNCTIONALITY PRIOR TO THE SECOND OCCURRENCE AND NO PROBLEMS WERE FOUND. TWO WHILE LEVEL SENSOR PADS WERE RETURNED TO SORIN GROUP USA FOR EVAL. VISUAL INSPECTION DID NOT FIND ANY DEFECTS IN THE MOUNTING PADS. THE INVESTIGATION NOTED THAT THE RETURNED MOUNTING PADS WERE NO LONGER STICKY ENOUGH TO BE VIABLE FOR PERFORMANCE TESTING. REP MOUNTING PADS WERE PULLED FROM INVENTORY FOR SIMULATED USE/PERFORMANCE TESTING. TESTING DID NOT DUPLICATE THE REPORTED PROBLEM. THE PADS FUNCTIONED PROPERLY, STOPPING THE PUMP WHEN THE LEVEL REACHED THE CENTER OF THE PADS. NO PROBLEM WAS DETECTED. ADD'L INFO WILL BE FORWARDED IN A F/U REPORT.

    Description of Event or Problem · 1

    SORIN GROUP USA RECEIVED A COMPLAINT REPORTING TWO OCCASIONS WHERE, WHEN THE BLOOD LEVEL DROPPED BELOW THE LEVEL SENSOR, THE SENSOR WAS TRIGGERED BUT NO ALARM WAS PRODUCED AND THE ERC WAS NOT ACTIVATED. THERE WAS NO REPORT OF PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STOCKERT S3 LEVEL SENSOR MOUNTING PADS MONITOR AND/OR CONTROL, LEVEL SENSING, CARIOPULMONARY BYPASS DTW SORIN GROUP DEUTSCHLAND 23-27-41 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1