BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIPOD HEART STABILIZER - NYLON FASTRACT

    MDR report key: 3560472 · Received October 2, 2013

    Report

    Report Number
    1649139-2013-00001
    Event Type
    Malfunction
    Date Received
    October 2, 2013
    Date of Event
    February 21, 2013
    Report Date
    February 21, 2013
    Manufacturer
    CHASE MEDICAL
    Product Code
    MWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED IN THE ORIGINAL SHIPPER BOX WITH SHIPPER LABELS PRESENT. THE INNER TRAY AND POUCH WERE NOT RETURNED. THE PRODUCT WAS NEVER USED AND WAS NOT CONTAMINATED. ONE FOOT WAS SEPARATED FROM THE STABILIZER AND THE O-RING WAS MISSING. THE LOT HISTORY RECORD WAS REVIEWED FOR LOT D203020. THE WORK ORDER WAS MANUFACTURED AND INSPECTED PER PROCEDURE. A 100% INSPECTION IS IN PLACE AFTER STERILIZATION TO LOOK FOR THIS DEFECT. PRIOR TO INVESTIGATION IN 2008 FOR SPLIT O-RINGS REVEALED, "THE DISCRETE FAILURE OF THE O-RING IS MOST LIKELY RELATED TO DAMAGE CAUSED DURING HANDLING AND PLACEMENT OF THE O-RING. THE INCIDENCE RATE OF THIS FAILURE TYPE, SPECIFICALLY ONCE THE DEVICE HAS BEEN THROUGH 100% POST-STERILIZATION INSPECTION IS VERY LOW. THIS POTENTIAL FAILURE MODE IS ALREADY KNOWN TO THE OPERATORS." DISCUSSION WITH THE VENDOR DID NOT PROVIDE ANY ANSWERS AS TO WHY THE O-RING SPLIT. THIS IS THE FIRST COMPLAINT OF A SPLIT O-RING SINCE THE 2008 INVESTIGATION. (B)(4). REVIEWED THE FAILURE MODE WITH THE OPERATORS, AND OPERATORS ARE AWARE OF THE NEED FOR CARE WHEN PLACING O-RINGS ON FOOT ADAPTER. THE FAILURE MODE WAS ADDRESSED DURING THE DESIGN CONTROL RISK ANALYSIS PROCESS. NO FURTHER ACTION WAS TAKEN FOR THIS DEVICE MALFUNCTION. THE COMPANY CONTINUE TO MONITOR COMPLAINTS FOR FURTHER OCCURRENCES.

    Description of Event or Problem · 1

    COMPLAINANT REPORTED THE O-RING CAME OFF OF THE STABILIZER FOOT AND ONE FOOT FELL OFF OF THE HEART STABILIZER. THIS WAS NOTED WHEN THE STABILIZER WAS REMOVED FROM ITS PACKAGING PRIOR TO USE. THE DEVICE WAS NOT USED ON A PT AND THERE WAS NO PT HARM AS A RESULT OF THIS FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498894 TRIPOD HEART STABILIZER - NYLON FASTRACT MWS CHASE MEDICAL STB-30C4S D203020

    Patients

    Seq Age Sex Outcome Treatment
    1