BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2834171 · Received November 15, 2012

    Report

    Report Number
    1416980-2012-05288
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Date of Event
    November 4, 2012
    Report Date
    November 4, 2012
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A REPORT OF A CONNECTION ISSUE WAS NOT CONFIRMED. THE ROOT CAUSE WAS UNDETERMINED. THE SAMPLE WAS UNAVAILABLE AND THE LOT NUMBER WAS UNKNOWN, THEREFORE NO EVALUATION OR BATCH REVIEW COULD BE PERFORMED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S SERVICE CENTER REGARDING A CONNECTION ISSUE, WHICH OCCURRED ON THE HOMECHOICE (HC) DURING USE; THE PATIENT WAS NOT CONNECTED. THE HEATER BAG HAD DISCONNECTED FROM THE SETUP. THE HOME PATIENT (HP) WANTED TO KNOW IF THAT WOULD EFFECT ANYTHING. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE HP TO START OVER WITH ALL NEW SUPPLIES. THE HP UNDERSTOOD AND WOULD START OVER. THERE WERE NO SAMPLES AVAILABLE AND THE LOT NUMBERS WERE NOT AVAILABLE. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. BAXTER PRODUCT SURVEILLANCE CONTACTED THE HOME PATIENT ON (B)(6) 2012. HE STATED THAT THE RED HEATER BAG HAD DISCONNECTED FROM THE SETUP AND THAT HE DID NOT NOTICE ANYTHING UNUSUAL ABOUT THE SUPPLIES THAT MAY HAVE CAUSED THE SEPARATION. AFTER STARTING OVER WITH NEW SUPPLIES, THERAPY WENT WELL. THERE WERE NO SAMPLES AVAILABLE AND HE DID NOT RECALL THE LOT NUMBER. THERAPY SINCE HAS BEEN GOING WELL AND THERE WERE NO ADVERSE EFFECTS REPORTED IN RELATION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR HOMECHOICE