BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NI

    MDR report key: 8011597 · Received October 28, 2018

    Report

    Report Number
    1416980-2018-06838
    Event Type
    Malfunction
    Date Received
    October 28, 2018
    Date of Event
    October 2, 2018
    Report Date
    November 30, 2018
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: (REMOVE SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE), (REMOVE KDJ), (REMOVE HOMECHOICE CASSETTE). THE CUSTOMER REPORTED THAT THE ISSUE WAS WITH THE HOMECHOICE CASSETTE AND NOT THE PATIENT EXTENSION SET AS PREVIOUSLY REPORTED. THE CUSTOMER STATED THAT THERE WAS A TINY HOLE ON THE CASSETTE LINE CAUSING THE LEAK. 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 HOME PATIENT (HP) WAS CONNECTED AT THE TIME OF THE ALARM. THIS OCCURRED DURING DRAIN THREE OF THREE OF PERITONEAL DIALYSIS THERAPY. DURING TROUBLESHOOTING, IT WAS REPORTED THAT THERE WAS A PIN HOLE IN THE PATIENT LINE EXTENSION WHICH CAUSED THE SOLUTION TO LEAK ALL OVER THE FLOOR. THE HP STATED THAT THEY PLACED A PIECE OF TAPE OVER THE HOLE. RENAL THERAPY SERVICES (RTS) ADVISED THE HP TO CLOSE THE CLAMPS AND TRANSFER SET, AND CYCLE POWER TO THE DEVICE. THE HP WAS ADVISED TO NOTIFY THE PERITONEAL DIALYSIS REGISTERED NURSE REGARDING THE ALARM. 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
    852556 NI SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    0 HOMECHOICE| HOMECHOICE CASSETTE