BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3943697 · Received July 18, 2014

    Report

    Report Number
    1416980-2014-23219
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Date of Event
    June 24, 2014
    Report Date
    June 25, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED WITH THE NAKED EYE, AND CRACKS IN THE CASSETTE WERE OBSERVED. FUNCTIONAL TESTING INCLUDED CLAMP FUNCTION, CLEAR PASSAGE, AND SIMULATED THERAPY TESTING WITH NO ISSUES NOTED. LEAK TESTING WAS PERFORMED AND FOUND LEAKING FROM THE CRACKS IN THE CASSETTE. A BATCH REVIEW WAS CONDUCTED, AND THERE WERE NO DEVIATIONS FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. UPON COMPLETION OF THE INVESTIGATION, THE REPORTED ISSUE OF LEAKS WAS VERIFIED DUE TO THE CRACKS FOUND IN THE CASSETTE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPOT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MEMBRANE OF THE CASSETTE LEAKED DURING USE ON THE HOME CHOICE (HC). NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED AS A RESULT OF THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421260 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME H14D23024

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE