BEUDAMED
    FDA Adverse Event Other Summary report: N

    STOCKERT S3 LEVEL SENSOR MOUNTING PADS

    MDR report key: 2686890 · Received August 2, 2012

    Report

    Report Number
    1718850-2012-00919
    Event Type
    Other
    Date Received
    August 2, 2012
    Date of Event
    April 4, 2012
    Report Date
    July 3, 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
    FR
    Reporter Occupation
    UNKNOWN

    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 IN (B)(6). IT WAS REPORTED TO SORIN GROUP THAT THE SAME LEVEL SENSOR HAS BEEN USED FOR THE LAST THREE MONTHS WITHOUT ANY PROBLEMS. SORIN GROUP (B)(4) HAS REQUESTED FOR ALL OF THE INVOLVED PRODUCT TO BE RETURNED FOR EVAL. THE INVESTIGATION IS ON-GOING. A FOLLOW-UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP RECEIVED A REPORT FROM A CUSTOMER THAT DURING A CASE, THE LEVEL SENSOR DID NOT DETECT THE LEVEL. THE LEVEL SENSOR WAS CHANGED OUT BUT THE PROBLEM PERSISTED. THE CASE WAS FINISHED WITHOUT THE LEVEL SENSOR. THERE WAS NO PT INJURY.

    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 DTW SORIN GROUP DEUTSCHLAND 23-27-41 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1