BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3013953 · Received March 21, 2013

    Report

    Report Number
    1416980-2013-06781
    Event Type
    Malfunction
    Date Received
    March 21, 2013
    Date of Event
    February 26, 2013
    Report Date
    February 26, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED ISSUE OF LEAK WAS CONFIRMED DURING THE SAMPLE EVALUATION OF THE MASTER COMPLAINT, (B)(4). A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT.

    Additional Manufacturer Narrative · 1

    (B)(4). A EVALUATION OF THE ACTUAL SAMPLE WAS CONDUCTED AND ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE EVALUATION. A VISUAL INSPECTION PERFORMED WITH NO ISSUES NOTED. LEAK TESTING WAS PERFORMED ON ALL COMPONENTS WITH THE FOLLOWING ISSUES NOTED: LEAKING FROM SPLIT IN SHEETING AT CORNER OF CASSETTE. CLEAR-PASSAGE TESTING WAS PERFORMED WITH NO ISSUES NOTED. CLAMP FUNCTION TEST WAS PERFORMED WITH NO ISSUES NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A BAXTER QUALITY SPECIALIST THAT DURING EVALUATION OF THE SAMPLE IN THE MASTER COMPLAINT FOR A SYSTEM ERROR 2240 ALARM, A LEAK WAS FOUND ON THE CASSETTE AT THE CORNER SEAL FROM A SPLIT IN SHEETING. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118100 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME H12K24053

    Patients

    Seq Age Sex Outcome Treatment
    1