BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 6421022 · Received March 21, 2017

    Report

    Report Number
    1416980-2017-02494
    Event Type
    Injury
    Date Received
    March 21, 2017
    Date of Event
    February 28, 2017
    Report Date
    March 21, 2017
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 A SOLUTION 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 FILL TWO OF FIVE OF PERITONEAL DIALYSIS THERAPY. DURING THE TROUBLESHOOTING, IT WAS REPORTED THAT THERE WAS A DISCONNECTION BETWEEN THE SOLUTION BAG AND THE SUPPLY LINE WHICH RESULTED IN THE ENTIRE SOLUTION BAG LEAKING ON THE PATIENT¿S FLOOR. THE TECHNICAL SERVICE REPRESENTATIVE ASSISTED WITH CLEARING THE ALARM AND ENDING THERAPY. 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
    203697 NI SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR HOMECHOICE