BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2981641 · Received February 27, 2013

    Report

    Report Number
    1416980-2013-04873
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    February 20, 2013
    Report Date
    February 20, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A SYSTEM ERROR 2240 (AIR IN SET) IS NOT CONFIRMED BECAUSE DISPOSABLE SET WAS NOT RETURNED TO BAXTER FOR EVALUATION, LOT NUMBER WAS NOT PROVIDED FOR A BATCH REVIEW AND USER DID NOT DESCRIBE ANY TYPES OF USE ERRORS OR OTHER ISSUES THAT MIGHT HAVE CAUSED THE REPORTED EVENT. THE ASSIGNABLE CAUSE IS UNDETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED. THE LOT NUMBER IS UNKNOWN; THEREFORE A BATCH REVIEW WILL NOT BE CONDUCTED. WHEN THE EVALUATION IS COMPLETE, OR IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYSTEM ERROR (SE) 2240/2367 (AIR IN SET) ALARMS OCCURRED DURING INITIAL DRAIN ON THE HOME CHOICE (HC). THE COMPANY REPRESENTATIVE EXPLAINED THE ALARM MESSAGE TO THE HOME PATIENT (HP) ADVISED THE HP TO START OVER USING NEW SUPPLIES AND TO INFORM THEIR NURSE. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83372 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR HOMECHOICE