BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3163447 · Received June 11, 2013

    Report

    Report Number
    1416980-2013-15036
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    May 18, 2013
    Report Date
    May 18, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN ALARM INDICATIVE OF A POTENTIAL MALFUNCTION OF THE DISPOSABLE CASSETTE WAS IDENTIFIED. AS THE CASSETTE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HOME PATIENT (HP) HAD AIR IN THE PATIENT LINE. THIS HAD OCCURRED DURING THE INITIAL DRAIN, WHILE THE HP WAS CONNECTED TO THE HOMECHOICE (HC). THE CARE GIVER (CG) AND THE HP COULD NOT REMEMBER IF THE PATIENT LINE HAD BEEN PROPERLY PRIMED BEFORE THE THERAPY WAS INITIATED. DURING TROUBLESHOOTING NOTHING UNUSUAL WAS FOUND WITH THE SUPPLIES. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE CG WITH ENDING THE THERAPY BY CYCLING THE POWER. THE TSR ADVISED THE CG TO START THE THERAPY OVER, USING ALL NEW SUPPLIES. THERE WAS PATIENT INVOLVEMENT, HOWEVER THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264705 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR HOMECHOICE