BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 3122898 · Received May 21, 2013

    Report

    Report Number
    1416980-2013-13065
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    April 29, 2013
    Report Date
    April 30, 2013
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). AN ALARM INDICATIVE OF A POTENTIAL MALFUNCTION OF THE DISPOSABLE CASSETTE WAS IDENTIFIED. AS THE CASSETTE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MACHINE ALARMED SYSTEM ERROR 2240 DUE TO HEATER BAGS NOT BEING CONNECTED PROPERLY, AIR GOT INTO THE SYSTEM DURING PRIMING. THE PATIENT WAS NOT CONNECTED AT THE TIME OF ALARM. THERE WAS NO PATIENT INVOLVED. THERE WAS NO REPORTED INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224901 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX

    Patients

    Seq Age Sex Outcome Treatment
    1