BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1904463 · Received November 22, 2010

    Report

    Report Number
    1423500-2010-06078
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    October 30, 2010
    Report Date
    October 30, 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). DURING INVESTIGATION BY BAXTER, THIS INCIDENT WAS DETERMINED TO BE CAUSED BY USE/USER ERROR AND THERE WAS NO ALLEGATION OF A PRODUCT MALFUNCTION. THEREFORE, A BATCH REVIEW AND SAMPLE EVALUATION WILL NOT BE CONDUCTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A SYSTEM ERROR 2240 WAS NOT CONFIRMED DUE TO THE LACK OF A SAMPLE; HOWEVER, BASED ON THE INFORMATION GATHERED DURING BAXTER'S INVESTIGATION, THE CAUSE OF THE SYSTEM ERROR 2240 WAS DUE TO AIR BEING SUCKED INTO THE DISPOSABLE SET AFTER THE PATIENT LEFT A CLAMP OPEN ON AN UNUSED SUPPLY LINE. THE LOT INFORMATION WAS UNKNOWN; THEREFORE A BATCH REVIEW WAS NOT PERFORMED. A REVIEW OF THE LABELING REVEALS THAT THE HOMECHOICE APD SYSTEMS AT-HOME GUIDE IS SUFFICIENT FOR THE USER ERROR FOUND IN THIS COMPLAINT. BAXTER HAS RECEIVED SIMILAR REPORTS. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Description of Event or Problem · 1

    A PATIENT CONTACTED GLOBAL TECHNICAL SERVICES (GTS) REGARDING ASSISTANCE WITH A SYSTEM ERROR 2240 WHILE USING THE HOMECHOICE (HC) DURING DWELL 2 OF 4. GTS EXPLAINED THAT A LARGE AMOUNT OF AIR HAD ENTERED INTO THE DISPOSABLE SET, AND HAD THE PATIENT CYCLE POWER TWICE TO CLEAR THE ERROR. THE PATIENT HAD LEFT THE FINAL LINE CLAMP OPEN. GTS EXPLAINED THAT THE PATIENT WOULD NEED TO START OVER WITH NEW SUPPLIES OR FINISH USING MANUAL SUPPLIES. THE PATIENT STATED THAT SHE JUST WANTED TO DRAIN OUT WITH MANUAL SUPPLIES AND THEN GO TO BED. GTS ADVISED THE PATIENT TO CALL THEIR NURSE WITHIN THE NEXT 24 HOURS AND LET HER KNOW WHAT HAD HAPPENED. PRODUCT SURVEILLANCE CONTACTED THE PATIENT'S NURSE REGARDING THE REPORTED SYSTEM ERROR. THE NURSE WAS NOT AWARE OF THIS REPORT BUT SPOKE WITH THE PATIENT YESTERDAY AND STATED THAT THE PATIENT IS DOING FINE. THE NURSE WOULD REVIEW PROPER PROCEDURES WITH THE PATIENT THE NEXT TIME SHE TALKS TO HER. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    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 61 YR