BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 4182022 · Received October 17, 2014

    Report

    Report Number
    1416980-2014-36304
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 23, 2014
    Report Date
    September 23, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 FOR ANALYSIS; THEREFORE, NO EVALUATION COULD BE PERFORMED. HOWEVER, A DISCONNECTION BETWEEN THE PATIENT LINE AND THE TRANSFER SET WAS REPORTED, DUE TO A LOOSE CONNECTION, WHICH IS KNOWN TO CAUSE THIS ALARM. IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, THEN A FOLLOW-UP MDR 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 DRAIN FIVE OF FIVE. DURING THE TROUBLESHOOTING, IT WAS DETERMINED THAT THE PATIENT LINE DISCONNECTED FROM THE TRANSFER SET DUE TO A LOOSE CONNECTION. THE CARE GIVER EXPLAINED THAT THE HOME PATIENT RECONNECTED TO THE PATIENT LINE WHEN THE DEVICE ALARMED. THE TECHNICAL SERVICE REPRESENTATIVE ASSISTED WITH CLEARING THE ALARM AND THE PATIENT WAS GOING TO COMPLETE THE THERAPY MANUALLY. DURING THE FOLLOW UP, A NURSE REPORTED NOT KNOWING ANYTHING ABOUT THE EVENT BECAUSE THE PATIENT AND CARE GIVER DID NOT MENTION HAVING ANY ISSUES AND WERE COMPLETING THERAPY WITHOUT PROBLEMS. 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
    660270 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR TRANSFER SET, HOMECHOICE