BEUDAMED
    FDA Adverse Event Other Summary report: N

    STOCKERT S3 LEVEL SENSOR MOUNTING PADS

    MDR report key: 2418279 · Received January 6, 2012

    Report

    Report Number
    1718850-2011-00282
    Event Type
    Other
    Date Received
    January 6, 2012
    Date of Event
    August 6, 2011
    Report Date
    August 26, 2011
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    DWA
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURE DATE WILL BE PROVIDED IF MADE AVAILABLE. 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 REPORT THAT THE LEVEL SENSOR FAILED TO ALARM AFTER THE OXYGENATOR BLOOD LEVEL HAD DROPPED BELOW THE SENSOR PAD. THERE WAS NO REPORT OF PT INVOLVEMENT. TWO WHITE LEVEL SENSOR PADS WERE RETURNED TO SORIN GROUP FOR EVAL. VISUAL INSPECTION DID NOT FIND ANY DEFECTS IN THE MOUNTING PADS. THE INVESTIGATOR 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 A F/U REPORT.

    Description of Event or Problem · 1

    SORIN GROUP USA RECEIVED A REPORT THAT THE LEVEL SENSOR FAILED TO ALARM AFTER THE OXYGENATOR VOLUME HAD DROPPED BELOW THE SENSOR PAD. 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, CARDIOPULMONARY BYPASS DWA SORIN GROUP DEUTSCHLAND 23-27-41 1012500070

    Patients

    Seq Age Sex Outcome Treatment
    1