BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 4230716 · Received November 6, 2014

    Report

    Report Number
    1416980-2014-39086
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    October 13, 2014
    Report Date
    October 13, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN ALARM INDICATIVE OF A POTENTIAL MALFUNCTION OF THE DISPOSABLE CASSETTE WAS IDENTIFIED. THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER OF THE DEVICE WAS UNKNOWN; THEREFORE, A SAMPLE ANALYSIS AND/OR A BATCH REVIEW COULD NOT BE COMPLETED. AFTER REVIEW, THE CAUSE OF THE REPORTED EVENT WAS UNABLE TO BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SYSTEM ERROR 2240 (AIR IN SET/LINE) ALARM OCCURRED ON THE HOMECHOICE DEVICE DURING DWELL THREE OF FIVE. THE HOME PATIENT WAS CONNECTED AT THE TIME OF THE ALARM. DURING TROUBLESHOOTING, THERE WAS NOTHING UNUSUAL NOTED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE ALARM. THE TECHNICAL SERVICE REPRESENTATIVE REVIEWED PROPER PROCEDURES WITH THE PATIENT, EXPLAINED THE ALARM TO THE PATIENT, ASSISTED THE PATIENT TO CLEAR THE ALARM, AND ADVISED THE PATIENT TO BEGIN THERAPY AGAIN WITH ALL NEW SUPPLIES OR RESUME THERAPY WITH MANUAL BAGS. THE HOME PATIENT WOULD COMPLETE THERAPY USING MANUAL EXCHANGE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716000 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR HOMECHOICE