BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2902139 · Received January 8, 2013

    Report

    Report Number
    1416980-2013-00527
    Event Type
    Malfunction
    Date Received
    January 8, 2013
    Date of Event
    December 16, 2012
    Report Date
    December 16, 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). THE PROBLEM WAS CONFIRMED. THE ROOT CAUSE WAS UNDETERMINED. THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE USE ERROR IN THIS COMPLAINT. THERE WAS NO ALLEGATION REPORTED AGAINST THE BAXTER PRODUCT BY THE CUSTOMER; THEREFORE, THE SAMPLE WAS NOT REQUESTED FOR EVALUATION AND A SAMPLE EVALUATION WILL NOT BE CONDUCTED. THE LOT NUMBER WAS NOT PROVIDED, THEREFORE NO BATCH REVIEW COULD BE PERFORMED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED A BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) REGARDING A CHECK HEATER LINE ALARM THAT APPEARED ON THE DISPLAY OF THE HOME PATIENT'S (HP) HOMECHOICE (HC) MACHINE DURING FILL 1, DURING USE, PATIENT CONNECTED. FILL VOLUME = 61 ML. THE HP STATED THAT SHE HAD CHANGED OUT JUST THE HEATER BAG PER THE REGISTERED NURSES ADVICE. THE TSR EXPLAINED TO THE HP THAT THE SETUP IS COMPROMISED, ASSISTED THE HP IN ENDING THE THERAPY AND ADVISED THE HP TO START OVER WITH NEW SUPPLIES. THE HC IS OPERATIONAL. PER INITIAL REPORT, BAXTER'S TECHNICAL SERVICE CENTER ASSISTED THE CUSTOMER IN EVALUATING AND RESOLVING THE ALARM DURING THE INITIAL CONTACT. THERE WAS PATIENT INVOLVEMENT. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED AT THE TIME OF THE INITIAL REPORT. PRODUCT SURVEILLANCE RECEIVED A CALL FORM THE HOME PATIENT ON (B)(6) 2013 IN AND SHE SAID THAT SHE HAS BEEN COMPLETING THERAPY SUCCESSFULLY SINCE THEN. SHE STARTED OVER WITH NEW SUPPLIES THAT DAY AFTER CONTACTING BAXTER. THERE WAS PATIENT INVOLVEMENT BUT NO REPORTED INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8840 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR HOME CHOICE