BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2924529 · Received January 22, 2013

    Report

    Report Number
    1416980-2013-01478
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    December 31, 2012
    Report Date
    December 31, 2012
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT WAS CONFIRMED. THE CAUSE OF THE USE ERROR WAS UNDETERMINED. THIS REPORT OF USE ERROR WAS RECEIVED WITH NO ALLEGED DEVICE MALFUNCTION THEREFORE NO FURTHER INVESTIGATION WILL BE PERFORMED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A CHECK HEATER LINE (CHL) ALARM, WHICH OCCURRED ON THE HOMECHOICE (HC) DURING USE, DURING FILL. THE HOME PATIENT (HP) STATED THE HC ALARMED CHL IN FILL. THE HP STATED SHE CHANGED OUT THE CASSETTE BUT NOT THE SOLUTION BAGS. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) INFORMED THE HP WHEN STARTING OVER WITH NEW SUPPLIES THAT ALL THE SUPPLIES NEED TO BE CHANGED OUT AND NOT JUST THE CASSETTE. THE TSR ADVISED THE HP TO END THERAPY AND START OVER WITH ALL NEW SUPPLIES. THE HC WAS OPERATIONAL. THE SOLUTION TO THIS ISSUE WAS PROVIDED OVER THE PHONE AND A SWAP OF THE DEVICE WAS NOT NECESSARY. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. PRODUCT SURVEILLANCE CONTACTED THE HOME PATIENT ON (B)(4) 2013 AND SHE SAID SHE WAS ABLE TO RESUME THERAPY AFTER STARTING OVER WITH NEW SUPPLIES. SINCE THEN SHE HAS BEEN COMPLETING THERAPY SUCCESSFULLY. THERE WAS PATIENT INVOLVEMENT BUT NO REPORTED INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30491 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR HOME CHOICE