BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1963614 · Received January 19, 2011

    Report

    Report Number
    1423500-2011-00761
    Event Type
    Malfunction
    Date Received
    January 19, 2011
    Date of Event
    December 25, 2010
    Report Date
    December 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). THIS COMPLAINT FOR CHECK LINES AND BAGS ALARM WAS NOT CONFIRMED DUE TO UNAVAILABLE SAMPLE. A SAMPLE EVALUATION WAS NOT PERFORMED DUE TO UNAVAILABLE SAMPLE. THE LOT NUMBER IS UNKNOWN; THEREFORE A BATCH REVIEW CANNOT BE PERFORMED. A LABELING REVIEW OF THE HOMECHOICE APD SYSTEMS PATIENT AT-HOME GUIDE ISSUED WAS FOUND TO BE ADEQUATE FOR THE USE ERROR(S) IN THE COMPLAINT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (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 CAREGIVER CONTACTED GLOBAL TECHNICAL SERVICES (GTS) REGARDING ASSISTANCE WITH A CHECK LINES AND BAGS ALARM WHILE USING THE HOMECHOICE (HC) DURING THE PRIMING CYCLE. THE CAREGIVER STATED THE PATIENT WAS TRYING TO PRIME USING AN OLD CASSETTE AND SUPPLY BAGS. GTS EXPLAINED THAT THE PATIENT WOULD NEED TO SETUP WITH NEW SUPPLIES. THE CAREGIVER STATED THE PATIENT DISCONNECTED WITHOUT USING A MINICAP. GTS EXPLAINED THE PATIENT NEEDED TO CAP THE PATIENT LINE. THE CAREGIVER STATED THEY WOULD TRY TO FIND THEM OR WILL FOLLOW UP WITH THE PATIENT'S DIALYSIS NURSE. PRODUCT SURVEILLANCE CONTACTED THE PATIENT'S CAREGIVER WHO EXPLAINED THE PATIENT ELECTED TO STOP DIALYSIS TREATMENTS DUE TO AGE AND HEALTH CONDITION. THE CAREGIVER STATED THE PATIENT FOLLOWED UP WITH THEIR DIALYSIS NURSE REGARDING USAGE OF OLD SUPPLIES AND NOT USING A MINICAP WHEN DISCONNECTING. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMATED PD SET W/CASSETTE4 PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR HOMECHOICE APD CYCLER 5C4471R (REFURBISHED)