BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1941397 · Received December 29, 2010

    Report

    Report Number
    1423500-2010-07366
    Event Type
    Malfunction
    Date Received
    December 29, 2010
    Date of Event
    December 5, 2010
    Report Date
    December 5, 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 A LACK OF SAMPLE; HOWEVER, BASED ON THE INFORMATION OBTAINED BY BAXTER, THE CAUSE OF THE ERROR WAS AIR BEING SUCKED INTO THE DISPOSABLE AFTER AN INCOMPLETE PRIME. THE PATIENT STATED WHAT HE THOUGHT HAPPENED WAS HE FORGOT TO HIT THE BUTTON TO START PRIMING, AND UPON HOOKING UP, HE REALIZED AND HIT THE BUTTON TO PRIME. THE LOT NUMBER IS UNKNOWN THEREFORE A BATCH REVIEW WAS NOT PERFORMED. THE HOMECHOICE APD SYSTEMS PATIENT AT-HOME GUIDE INSTRUCTS PATIENTS TO CHECK FOR PROPER PRIMING IN THE PATIENT LINE, AND GIVES INSTRUCTION ON REPRIMING. THIS REVIEW FINDS THE LABELING ADEQUATE FOR THE USE ERROR(S) IN THE COMPLAINT. SIMILAR REPORTS HAVE BEEN RECEIVED. 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 PATIENT CONTACTED GLOBAL TECHNICAL SERVICES (GTS) REGARDING ASSISTANCE WITH A SYSTEM ERROR 2240 WHILE USING THE HOMECHOICE (HC) DURING THE INITIAL DRAIN. GTS HAD THE PATIENT CYCLE POWER TO CLEAR THE ERROR AND ADVISED STARTING OVER WITH NEW DISPOSABLES. PRODUCT SURVEILLANCE CONTACTED THE PATIENT WHO EXPLAINED THE LOT INFORMATION WAS UNKNOWN AND NO SAMPLES WERE AVAILABLE. THE PATIENT DID NOT NOTICE ANYTHING UNUSUAL WITH THE CASSETTE, BUT THOUGHT HE MAY HAVE FORGOTTEN TO HIT THE BUTTON TO PRIME, WHICH WAS NOTICED WHEN THE PATIENT CONNECTED TO START THERAPY. THE PATIENT EXPLAINED THAT HE THEN HIT THE BUTTON TO PRIME. THE PATIENT DID NOT NOTIFY THEIR NURSE AND WAS ADVISED TO DO SO. THE PATIENT STATED THERAPY WAS GOING WELL SINCE. 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 55 YR HOMECHOICE APD CYCLER (B)(4) (REFURBISHED)