BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3122331 · Received May 21, 2013

    Report

    Report Number
    1416980-2013-13015
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 1, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS REPORTED TO BE AVAILABLE BUT HAS NOT BEEN RECEIVED AT THIS TIME. SHOULD THE DEVICE BE RECEIVED OR ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT AVAILABLE FOR EVALUATION AFTER MULTIPLE ATTEMPTS WERE MADE TO RETRIEVE IT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FLUID WAS LEAKING FROM THE CASSETTE DURING PRIMING, PRIOR TO PATIENT CONNECTION. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE HOME PATIENT (HP) TO START OVER WITH NEW SUPPLIES AND THE HP COMPLIED. THERE WAS NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED IN ASSOCIATION WITH THIS REPORT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223647 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR HOMECHOICE| UNKNOWN PERITONEAL DIALYSIS SOLUTION