BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3011599 · Received March 19, 2013

    Report

    Report Number
    1416980-2013-06629
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Date of Event
    February 22, 2013
    Report Date
    February 22, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ROOT CAUSE OF THE SYSTEM ERROR 2240 WAS AN INCOMPLETE PRIME. THE SAMPLE WAS UNAVAILABLE AND THE LOT NUMBER WAS UNKNOWN, THEREFORE NO EVALUATION OR BATCH REVIEW COULD BE PERFORMED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S SERVICE CENTER REGARDING A SYSTEM ERROR 2240 (AIR IN TUBING) WHICH OCCURRED ON THE HOMECHOICE (HC) DURING INITIAL DRAIN; THE PATIENT WAS CONNECTED. THE PATIENT LINE HAD NOT BEEN PROPERLY PRIMED PRIOR TO CONNECTING. NO PATIENT EXTENSIONS WERE IN USE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE HP CYCLE THE POWER ON HC, AND IT THEN ALARMED SYSTEM ERROR 2367. THE TSR HAD THE HP TURN THE HC OFF AND EXPLAINED BOTH SYSTEM ERRORS TO THE HP. THE TSR ADVISED THE HP TO START OVER WITH ALL NEW SUPPLIES. THE TSR ADVISED THE HP TO CALL US BACK IF NEEDED US TO FURTHER ASSISTED WITH PRIMING THE PATIENT LINE. THE HP UNDERSTOOD. PROPER PROCEDURES WERE REVIEWED. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113604 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR HOMECHOICE