BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1901192 · Received November 17, 2010

    Report

    Report Number
    1423500-2010-05858
    Event Type
    Malfunction
    Date Received
    November 17, 2010
    Date of Event
    October 25, 2010
    Report Date
    October 25, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED. SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT IS FOR A REPORT OF A PATIENT NOT FULLY INSERTING A SPIKE INTO A SUPPLY BAG AND THE SPIKE "POPPED OUT." THIS COMPLAINT WAS NOT CONFIRMED IN THE LAB DUE TO A LACK OF SAMPLE. THE LOT NUMBER IS UNKNOWN THEREFORE A BATCH REVIEW WAS NOT PERFORMED. THE ROOT CAUSE IS UNDETERMINED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    A CARE GIVER (CG) CONTACTED GLOBAL TECHNICAL SERVICES REGARDING A BAG THAT BECAME DISCONNECTED ON THE HOMECHOICE (HC) MACHINE DURING SET UP. THE CG EXPLAINED THAT THE SPIKE GOING INTO THE HEATER BAG WAS NOT QUITE IN AS FAR AS IT COULD GO. WHILE TRYING TO FIX IT, THE SPIKE "POPPED OUT", BUT THEN WAS IMMEDIATELY INSERTED INTO THE HEATER BAG. THE CG WANTED TO KNOW IF IT WOULD BE A PROBLEM AT ALL. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED IF THE SPIKE WAS EXPOSED TO THE OPEN AIR AND THEN REINSERTED INTO THE HEATER BAG, THEN THERE COULD BE A CHANCE FOR CONTAMINATION. THE TSR SUGGESTED THAT THE CG START OVER WITH NEW SUPPLIES IN ORDER TO AVOID A CONTAMINATION ISSUE AND TO CALL BACK WITH ANY PROBLEMS. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRATED APD SET W/CASSETTE3-PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR