BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2901385 · Received January 8, 2013

    Report

    Report Number
    1416980-2013-00491
    Event Type
    Malfunction
    Date Received
    January 8, 2013
    Date of Event
    December 10, 2012
    Report Date
    December 10, 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 USE ERROR BREACH IN ASEPTIC TECHNIQUE WAS CONFIRMED AS IT WAS REPORTED THAT THE PATIENT DROPPED ONE OF THE LINES ONTO THE FLOOR. THE ROOT CAUSE WAS UNDETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS UNAVAILABLE AND THE LOT NUMBER WAS UNKNOWN, THEREFORE NO EVALUATION OR BATCH REVIEW COULD BE PERFORMED. A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    THE HOME PATIENT (HP) CONTACTED BAXTER'S SERVICE REGARDING A SYSTEM ERROR 2084 AND SYSTEM ERROR 2265 THAT OCCURRED ON THE HOMECHOICE (HC) DURING USE DURING THE INITIAL DRAIN; THE PATIENT WAS CONNECTED. THE HOME PATIENT (HP) COMPROMISED SUPPLIES AND WAS TRYING TO START OVER WITH NEW SUPPLIES. THE ONE OF THE UNUSED LINES HAD FALLEN OUT OF THE ORGANIZER AND ONTO THE FLOOR. IT WAS UNKNOWN IF THE UNUSED LINE WAS CLAMPED AND CAPPED. THE HP THEN OPENED THE CASSETTE DOOR TO START OVER WITH NEW SUPPLIES AND THE ALARM SOUNDED. THE TECHNICAL SERVICE REPRESENTATIVE EXPLAINED THE ALARMS AND HAD THE HP CYCLE THE POWER TO CLEAR THEM. THE HP UNDERSTOOD THE EXPLANATIONS, CLEARED THE ALARMS, AND WOULD START OVER WITH NEW SUPPLIES. THE HC WAS OPERATIONAL AND A SWAP OF THE DEVICE WAS NOT NECESSARY. THERE WAS NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED. BAXTER PRODUCT SURVEILLANCE CONTACTED THE REGISTERED NURSE ON (B)(4) 2013. SHE STATED THAT SHE WAS NOT AWARE OF THE INCIDENT, BUT THE PATIENT'S THERAPY HAS BEEN GOING WELL SINCE. NO ADVERSE EFFECTS WERE REPORTED IN RELATION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8760 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR HOMECHOICE