BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3171748 · Received June 17, 2013

    Report

    Report Number
    1416980-2013-15480
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    May 22, 2013
    Report Date
    May 22, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A SAMPLE WAS NOT RETURNED AND THE LOT NUMBER IS NOT AVAILABLE; THEREFORE, A SAMPLE ANALYSIS CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SOLUTION BAG WOULD NOT CONNECT TO A LINE ON AN INTEGRATED AUTOMATIC PERITONEAL DIALYSIS SET. THE HOME PATIENT (HP) WAS USING A SET WITH LUER LINES AND THE SOLUTION BAG DID NOT FIT THE LUER. THE SOLUTION BAG CONTAINED ANTIBIOTICS, HOWEVER, THE HP WAS UNABLE TO SAY WHAT THE ANTIBIOTIC WAS BEING ADMINISTERED FOR. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE HP TO CONTACT HER REGISTERED NURSE (RN) OR DOCTOR TO LET THEM KNOW. THERE WAS NO ADVERSE EVENT INDICATED IN ASSOCIATION WITH THIS REPORT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273151 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR UNKNOWN ANTIBIOTIC, SOLUTION BAG