BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2923027 · Received January 18, 2013

    Report

    Report Number
    1416980-2013-01441
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Date of Event
    December 26, 2012
    Report Date
    December 26, 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). 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 PROBLEM WAS CONFIRMED, AS IT WAS REPORTED THAT THE HP HAD LEFT THE PATIENT LINE UNCAPPED. THE ROOT CAUSE WAS DETERMINED TO BE A USE ERROR. A REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. THE LOT NUMBER WAS NOT PROVIDED, THEREFORE NO BATCH REVIEW COULD BE PERFORMED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED GLOBAL TECHNICAL SERVICES (GTS) REGARDING A LOW DRAIN VOLUME (LDV) ALARM AND A LEAK, WHICH OCCURRED ON THE HOMECHOICE (HC) UNIT DURING THERAPY. THE DRAIN VOLUME (DV) AT THE TIME OF THE ALARM WAS 2170ML. THE HOME PATIENT (HP) STATED HE WAS NOT CONNECTED DURING FILL 1 AND FLUID HAD LEAKED ON THE FLOOR, AS THE HP DID NOT HAVE A FLEXICAP ON THE PATIENT LINE. THE TECHNICAL SERVICES REPRESENTATIVE (TSR) HELPED THE CALLER END THERAPY. THE TSR ALSO TOLD CALLER TO CALL THEIR NURSE ABOUT RECONNECTING AFTER THE FILL STARTED AND NOT HAVING A CAP ON THE PATIENT LINE. THE HP WOULD DISCARD SUPPLIES AND 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. THE HP WAS CONTACTED ON (B)(6) 2013 AND THE HP HAD STARTED OVER WITH NEW SUPPLIES THAT DAY AFTER THE ISSUE. HE DID CONTACT HIS NURSE AND HAS BEEN COMPLETING THERAPY SUCCESSFULLY SINCE THEN. THERE WAS PATIENT INVOLVEMENT, BUT NO REPORTED INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27454 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR HOME CHOICE