BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3822042 · Received May 20, 2014

    Report

    Report Number
    1416980-2014-16307
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    April 25, 2014
    Report Date
    April 25, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AIR IN THE LINE, INDICATIVE OF A POTENTIAL MALFUNCTION OF THE DISPOSABLE CASSETTE, WAS IDENTIFIED. AS THE CASSETTE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING TROUBLESHOOTING FOR AN UNRELATED ALARM ON THE HOMECHOICE (HC) MACHINE, IT WAS REPORTED THAT THE CARE GIVER (CG) SAW AIR IN THE HEATER LINE WITHOUT AN ASSOCIATED ALARM. THIS WAS NOTICED DURING THE DRAIN STEP OF PERITONEAL DIALYSIS (PD) THERAPY. NOTHING WAS FOUND DURING TROUBLESHOOTING THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE AIR. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT THAT WAS CAUSALLY RELATED TO A BAXTER DEVICE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299760 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR HOMECHOICE