BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2821683 · Received November 6, 2012

    Report

    Report Number
    1416980-2012-04208
    Event Type
    Malfunction
    Date Received
    November 6, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 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 LABELING 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.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR (SE) 2240/2367 ALARM, WHICH OCCURRED ON THE HOMECHOICE (HC) DURING USE, DURING DWELL 1 OF 3. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) RECYCLED POWER AND CLEARED AND EXPLAINED THE ALARMS. THE MACHINE WAS AT PRESS GO TO START AND THEY TOLD THE CALLER TO DISCARD THE SUPPLIES. THEY WOULD START OVER WITH NEW SUPPLIES. THE CALLER WANTED TO USE THE SAME SUPPLIES TO DRAIN OUT AND THE TSR RECOMMENDED NOT TO. THEY TOLD THE CALLER TO CALL THE REGISTERED NURSE (RN) PER THE AIR DETECT ALARM AND THE HP BEING CONNECTED. THE CALLER INSISTED ON A SWAP. THEY HAD THE PRO CARD AND THE CALLER SAID THEY HAD REUSED SUPPLIES IN PAST THERAPIES. THE MACHINE WOULD BE SWAPPED. THE SOLUTION TO THIS ISSUE WAS PROVIDED OVER THE PHONE AND A SWAP OF THE DEVICE WAS NOT NECESSARY. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. PRODUCT SURVEILLANCE CONTACTED THE HOME PATIENT ON AND HE ALREADY DISCUSSED WITH THE TSR ABOUT NOT REUSING THE SAME SUPPLIES. SINCE THEN HE HAS BEEN COMPLETING THERAPY SUCCESSFULLY. THERE WAS PATIENT INVOLVEMENT BUT NO REPORTED INJURY OR MEDICAL INTERVENTION.

    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 65 YR HOME CHOICE