BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 4932141 · Received July 22, 2015

    Report

    Report Number
    1416980-2015-29754
    Event Type
    Malfunction
    Date Received
    July 22, 2015
    Date of Event
    July 1, 2015
    Report Date
    July 1, 2015
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN ALARM INDICATIVE OF A POTENTIAL MALFUNCTION OF THE DISPOSABLE CASSETTE WAS REPORTED. THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. 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 ALARM (AIR IN SET/LINE) OCCURRED ON THE HOMECHOICE DEVICE DURING DWELL FOUR OF FOUR IN PERITONEAL DIALYSIS. THE HOME PATIENT WAS CONNECTED AT THE TIME OF THE ALARM. THE TECHNICAL SERVICE REPRESENTATIVE EXPLAINED THE ALARM TO THE HOME PATIENT. THE TECHNICAL SERVICE REPRESENTATIVE HAD THE HOME PATIENT CYCLE THE POWER TO CLEAR THE ALARM AND ASSISTED TO RETRIEVE THE CASSETTE. THERE WAS NOTHING UNUSUAL NOTED WITH THE SUPPLIES OR THE SETUP THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE ALARM. 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
    476213 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR HOMECHOICE