BEUDAMED
    FDA Adverse Event Summary report: N

    TEMPERATURE PROBE

    MDR report key: 1981792 · Received January 17, 2011

    Report

    Report Number
    1516825-2011-00002
    Date Received
    January 17, 2011
    Date of Event
    September 8, 2009
    Report Date
    September 15, 2009
    Manufacturer
    CINCINNATI SUB-ZERO PRODUCTS, INC.
    Product Code
    FLL
    PMA / PMN Number
    K072621
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    HEALTH PROFESSIONAL'S IMPRESSION: ORIGINAL PROBE WAS REMOVED FROM THE PT AND DISCARDED. ANOTHER PROBE FROM THE SAME LOT NUMBER WAS TESTED BY BIOMED. IT PRODUCED THE SAME PROBLEM. FURTHER TESTING REVEALED THAT THERE WAS A PROBLEM WITH THE RJ-11 CONNECTOR. BIOMED TEST RESULT: BIOMED INITIALLY DUPLICATED COMPLAINT UNDER NORMAL SETUP CONDITIONS. THEN THEY CUT OFF RJ-11 AND CONNECTED DIRECTLY TO CABLE/DEVICE USING ALLIGATOR CLIPS. THE DEVICE RAN FOR SEVERAL HOURS WITH NO PROBLEMS. PHYSICAL EXAMINATION OF THE REMAINING CONNECTOR REVEALED THAT THE WIRES WERE LOOSELY ATTACHED AND PULLED OUT EASILY. CSZ IMPLEMENTED A CORRECTION TO THE CUSTOMER COMPLAINING ABOUT IT AND ON ALL NEW SHIPMENTS. CSZ HAS DISCONTINUED THESE DISPOSABLE PROBES (B)(4). NOTE: THIS MDR IS BEING FILED AS A RESULT OF RESPONSE TO SUBSEQUENT AUDIT FINDINGS REQUIRED IN THE WARNING LETTER CIN-10-93004-17, DATED 7/13/2010. THIS IS AN OLD COMPLAINT.

    Description of Event or Problem · 1

    THE MACHINE OPERATED FOR APPROX 6-8 HOURS THEN "CHECK PROBE" MESSAGE CAME ON AND THE MACHINE STOPPED WORKING IN THE MIDDLE OF ECMO THERAPY. THERE ARE ONLY 2 LEFT FROM THAT LOT NUMBER. THE DEPT RECENTLY ORDERED ANOTHER BATCH. THE SHEATHING LOOKS DIFFERENT SO THEY MAY HAVE CHANGED DESIGNS OR GONE TO ANOTHER SUPPLIER. BIOMED WAS MADE AWARE OF THIS SITUATION THROUGH A REPAIR CALL AND NOT AN OCCURRENCE REPORT. THE PT'S OUTCOME IN THIS CASE IS UNK. WE LEARNED THAT THE DEPT HAD BEEN DEALING WITH THIS ISSUE FOR A WHILE AND RECTIFYING THE PROBLEM ON THE FLOOR BY SWAPPING OUT PROBES. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TEMPERATURE PROBE THERMAL REGULATING SYSTEM FLL CINCINNATI SUB-ZERO PRODUCTS, INC. 491B D727416

    Patients

    Seq Age Sex Outcome Treatment
    1 Other