BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1770996 · Received July 27, 2010

    Report

    Report Number
    1423500-2010-01655
    Event Type
    Malfunction
    Date Received
    July 27, 2010
    Date of Event
    May 9, 2010
    Report Date
    May 9, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS NOT AVAILABLE AS IT HAS BEEN DISCARDED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S (B)(4) REGARDING A SYSTEM ERROR 2240 / 2367 ALARM (AIR IN LINE) THAT APPEARED ON THE HOMECHOICE (HC) UNIT DURING DWELL 3 OF 5. THERE WAS AN OPEN CLAMP ON AN UNUSED SUPPLY LINE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THAT THE HOME PATIENT (HP) WOULD HAVE TO START OVER WITH NEW SUPPLIES. THE HP STATED THAT SHE WANTS TO JUST FINISH FOR THE NIGHT. THE TSR ADVISED THE HP TO CALL THE NURSE. (B)(4) CONTACTED THE PATIENT ON (B)(6) 2010. ACCORDING TO THE PATIENT SHE DISCARDED SUPPLIES AND STARTED THERAPY OVER WITH NEW SUPPLIES. THE PATIENT HAS NOT HAD ANY FURTHER ISSUES. THE PATIENT STATED SHE NOTIFIED HER NURSE OF THE UNCLAMPED LINE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRATED APD SET W/CASSETTE3-PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR