BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3 PRONG

    MDR report key: 1964328 · Received January 19, 2011

    Report

    Report Number
    1423500-2011-00787
    Event Type
    Malfunction
    Date Received
    January 19, 2011
    Date of Event
    December 26, 2010
    Report Date
    December 26, 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). 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 AFTER THE PATIENT INITIATED THERAPY WITHOUT BEING CONNECTED. THE LOT INFORMATION WAS UNKNOWN; THEREFORE A BATCH REVIEW WAS NOT PERFORMED. REVIEW OF THE LABELING REVEALS THE HOMECHOICE APD SYSTEMS AT-HOME GUIDE CONTAINS SUFFICIENT LABELING FOR THE USER ERROR IN THIS COMPLAINT. SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH RENQ-CAPA-(B)(4).

    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, THE DEVICE WAS NOT REQUESTED FOR EVALUATION AND A BATCH REVIEW WILL NOT BE CONDUCTED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF BAXTER'S INVESTIGATION.

    Description of Event or Problem · 1

    A PATIENT CONTACTED (B)(4) REGARDING ASSISTANCE WITH A SYSTEM ERROR 2240 WHILE USING THE HOMECHOICE (HC) DURING THE INITIAL DRAIN CYCLE. THE PATIENT HAD PRESSED "GO" BEFORE CONNECTING FOR THERAPY, THEN CONNECTED HIMSELF. (B)(4) EXPLAINED THE SYSTEM ERROR INDICATED A LARGE AMOUNT OF AIR HAD ENTERED INTO THE DISPOSABLE SET AND HAD THE PATIENT CYCLE POWER TWICE TO CLEAR THE ERROR. (B)(4) THEN EXPLAINED THE PATIENT WOULD NEED TO START OVER WITH NEW SUPPLIES AND ADVISED THEM TO CONTACT THEIR DIALYSIS NURSE. PRODUCT SURVEILLANCE CONTACTED THE PATIENT'S CAREGIVER WHO EXPLAINED THE SYSTEM ERROR WAS AN ISOLATED EVENT. THE CAREGIVER ALSO EXPLAINED THE PATIENT DID NOT DEVELOP ANY ADVERSE REACTIONS OR REQUIRE ANY MEDICAL INTERVENTION. THE PATIENT WAS ABLE TO CONTINUE THERAPY WITHOUT ANY COMPLICATIONS.

    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 51 YR HOMECHOICE APD CYCLER (B)(4) (REFURBISHED)