BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3061126 · Received April 16, 2013

    Report

    Report Number
    1416980-2013-09401
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    March 22, 2013
    Report Date
    March 25, 2013
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD THE DEVICE BE RECEIVED BY BAXTER FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS VISUALLY INSPECTED AND A PIN HOLE WAS FOUND IN THE SHEETING. PRESSURE TESTING FOUND A LEAK COMING FROM THE HOLE. THE SAMPLE CONFIRMED THE REPORTED PROBLEM. THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A LEAK IN A CASSETTE. AIR WAS OBSERVED IN THE PATIENT LINE, AND THE LEAK WAS FOUND UPON REMOVING THE CASSETTE FROM THE HOMECHOICE. THERE WAS A PINHOLE IN THE CASSETTE SHEETING. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162505 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE