BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3082690 · Received April 29, 2013

    Report

    Report Number
    1416980-2013-10661
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 4, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN EVALUATION OF THE ACTUAL SAMPLE WAS CONDUCTED AND ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE EVALUATION. VISUAL INSPECTION PERFORMED WITH THE FOLLOWING ISSUES NOTED: CUT IN SHEETING. LEAK TESTING PERFORMED WITH THE FOLLOWING ISSUES NOTED: CUT IN SHEETING. CLEAR PASSAGE TEST PERFORMED WITH NO ISSUES NOTED. CLAMP FUNCTION TEST PERFORMED WITH NO ISSUES NOTED. CASSETTE SHEETING WAS REPLACED WITH LAB SHEETING AND RAN ON HOMECHOICE MACHINE WITH NO ALARMS NOTED. SAMPLE WAS CONFIRMED FOR THE REPORTED PROBLEM.

    Description of Event or Problem · 1

    DURING EVALUATION OF A HOMECHOICE, CASSETTE A LEAK WAS FOUND. THERE WAS A CUT IN THE CASSETTE SHEETING THAT CAUSED THE LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183907 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR