BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2933077 · Received January 29, 2013

    Report

    Report Number
    1416980-2013-02131
    Event Type
    Malfunction
    Date Received
    January 29, 2013
    Date of Event
    January 20, 2013
    Report Date
    January 20, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SUSPECT DEVICE INFO AND A 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR, BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME. PER THE CUSTOMER THE SAMPLE WAS DISCARDED AND THE LOT NUMBER WAS UNKNOWN, THEREFORE THE CONDITION CANNOT BE CONFIRMED OR DUPLICATED AND THE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED. THE EVALUATION AND BATCH REVIEW COULD NOT BE PERFORMED. A FOLLOW-UP REPORT WILL BE FILED IF ANY ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A LOW DRAIN VOLUME (LDV) ALARM, WHICH OCCURRED ON THE HOMECHOICE (HC) DURING USE, DURING DRAIN 3 OF 4. THE DRAIN VOLUME (DV) EQUALED 109ML. THE HOME PATIENT (HP) STATED SHE BECAME DISCONNECTED IN HER SLEEP AND THEN RECONNECTED BUT WAS GETTING A LDV ALARM. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THEM THEY WOULD NEED TO END THERAPY AND ALSO ADVISED THEM TO MAKE THE REGISTERED NURSE (RN) AWARE. THE CALL WAS COMPLETED AND 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38980 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR HOMECHOICE