BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2820010 · Received November 5, 2012

    Report

    Report Number
    1416980-2012-04110
    Event Type
    Malfunction
    Date Received
    November 5, 2012
    Date of Event
    October 13, 2012
    Report Date
    October 13, 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. A BATCH REVIEW COULD NOT BE CONDUCTED AS THE LOT NUMBER WAS UNKNOWN. A FOLLOW-UP MDR WILL BE SUBMITTED IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A LOW DRAIN VOLUME (LDV) ALARM, WHICH OCCURRED ON THE HOMECHOICE (HC) DURING DRAIN 1 AND 1. THE HOME PATIENT (HP) STATED, SHE DID THE DAY FILL AND DID NOT COMPLETE THE THERAPY. THE HP STATED, SHE SPOKE TO THE REGISTERED NURSE (RN) AND THE RN TOLD HER TO CONTINUE LIKE NORMAL. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) ASKED THE HP IF SHE STARTED OVER WITH NEW SUPPLIES. THE HP STATED NO; IT WAS THE SAME SUPPLIES BECAUSE SHE DID NOT COMPLETE THERAPY (THIS REPORT). THE TSR ASKED THE HP IF THE RN TOLD HER TO USE THESE SUPPLIES. THE HP STATED THE RN DID NOT STATE TO USE THE SAME SUPPLIES. THE TSR RECOMMENDED THE HP START OVER WITH NEW SUPPLIES. THE TSR HAD THE HP CLOSE THE CLAMPS, DISCONNECT AND CYCLE POWER. THE TSR EXPLAINED THE HP COULD START OVER WITH NEW SUPPLIES. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. PRODUCT SURVEILLANCE RECEIVED A CALL FROM THE HOME PATIENT AND THEY SAID THEY HAD ALREADY DISCUSSED WITH THE TSR THE IMPORTANCE OF NOT REUSING SUPPLIES. SHE STARTED OVER WITH NEW SUPPLIES THAT DAY AND COMPLETED THERAPY SUCCESSFULLY. SINCE THEN SHE 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 45 YR HOME CHOICE