BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NI

    MDR report key: 6453407 · Received April 3, 2017

    Report

    Report Number
    1416980-2017-02916
    Event Type
    Malfunction
    Date Received
    April 3, 2017
    Date of Event
    March 13, 2017
    Report Date
    April 3, 2017
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. HOWEVER, A LOOSE CONNECTION WAS REPORTED BETWEEN THE SUPPLY LINE OF THE HOMECHOICE CASSETTE AND THE SUPPLY BAG, WHICH IS KNOWN TO CAUSE THIS ALARM. THE CAUSE OF THE LOOSE CONNECTION COULD NOT 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 HOMECHOICE DEVICE EXPERIENCED A SYSTEM ERROR 2240 (AIR IN LINE/SET) ALARM. THE PATIENT WAS CONNECTED AT THE TIME OF THE ALARM. THIS OCCURRED DURING DWELL THREE OF PERITONEAL DIALYSIS THERAPY. THE PATIENT INDICATED THAT THE SUPPLY BAG BECAME DISCONNECTED FROM THE SUPPLY LINE. DURING THE TROUBLESHOOTING, IT WAS REPORTED THAT THERE WAS A LOOSE CONNECTION BETWEEN THE SUPPLY LINE AND THE SUPPLY BAG THAT LED TO THE DISCONNECTION AND THIS ALARM. THE TECHNICAL SERVICE REPRESENTATIVE REVIEWED PROPER PROCEDURE WITH THE PATIENT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234563 NI SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR HOMECHOICE