BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3070812 · Received April 22, 2013

    Report

    Report Number
    1416980-2013-09988
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Report Date
    March 27, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. AS THE SAMPLE WAS NOT RETURNED, A DEVICE ANALYSIS CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A SAMPLE WAS REQUESTED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PLASTIC SHEETING OF AN AUTOMATED PERITONEAL DIALYSIS SET, WITH CASSETTE, HAD BEEN DAMAGED. THE DAMAGED WAS EXPLAINED TO BE THE SHEETING ON THE CASSETTE BEING PARTIALLY OPENED, WHICH WAS FOUND PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT, THEREFORE NO ADVERSE EVENT WAS ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION WAS REQUESTED, HOWEVER NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173036 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME H12I28107

    Patients

    Seq Age Sex Outcome Treatment
    1