BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3041651 · Received April 8, 2013

    Report

    Report Number
    1416980-2013-08787
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    March 31, 2013
    Report Date
    March 31, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ROOT CAUSE FOR THE REPORTED SYSTEM ERROR (SE) 2240 ALARM WAS DETERMINED TO BE USE ERROR DUE TO AN OPEN CLAMP. PER BAXTER LABELING, USERS ARE INSTRUCTED THAT CLAMPS ON ANY UNUSED SOLUTION LINES MUST REMAIN CLOSED WHEN PERFORMIN PERITONEAL DIALYSIS THERAPY. HERE WAS NO ALLEGATION REPORTED AGAINST THE BAXTER PRODUCT BY THE CUSTOMER; THEREFORE, THE SAMPLE WAS NOT REQUESTED FOR EVALUATION AND A BATCH REVIEW WILL NOT BE CONDUCTED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED A FOLLOW-UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REPORTING A SYSTEM ERROR (SE) 2240 (AIR IN LINE) DURING THE INITIAL DRAIN ON THE HOME CHOICE (HC). THE TECHNICAL SERVICE REPRESENTATIVE (TSR) FOUND THAT THE HOME PATIENT (HP) FORGOT TO CLOSE OFF A SPARE SUPPLY LINE CAUSING THE 2240 ALARM IN THE INITIAL DRAIN. THE TSR EXPLAINED THE S/E 2240 AND CLEARED THE ALARMS SO THE HP MAY UNLOAD THE CASSETTE AND BAGS. IT WAS UNKNOWN IF THE HP WOULD RESET UP AGAIN. THE TSR REFERRED THE HP TO THE ON CALL NURSE FOR FURTHER MEDICAL INSTRUCTIONS. THERE WAS PATIENT INVOLVEMENT. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143933 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR HOMECHOICE