BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMIA AUTOMATED PD CYCLER SET

    MDR report key: 11007823 · Received December 15, 2020

    Report

    Report Number
    1416980-2020-07765
    Event Type
    Malfunction
    Date Received
    December 15, 2020
    Date of Event
    November 19, 2020
    Report Date
    January 19, 2021
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    PMA / PMN Number
    K151525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    BRAND NAME IS AMIA AUTOMATED PD CYCLER SET. CATALOGUE # IS 5C5479. DEVICE MANUFACTURER NAME: BAXTER HEALTHCARE - MOUNTAIN HOME. PMA/510K IS K151525. ONE ACTUAL SAMPLE WAS RETURNED FOR EVALUATION WITH THE PATIENT CONNECTOR ATTACHED TO THE FEMALE CONNECTOR OF A TRANSFER SET. THE FEMALE CONNECTOR WAS CONNECTED, DISCONNECTED, AND LEAK TESTED WITH THE AMIA CONNECTOR WITH NO ISSUES NOTED. THE REPORTED CONDITION WAS NOT VERIFIED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED AND IS CURRENTLY AWAITING EVALUATION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS DIFFICULTY DISCONNECTING THE FEMALE CONNECTOR OF THE TRANSFER SET FROM THE PATIENT LINE OF THE HOMECHOICE CASSETTE. IT WAS FURTHER REPORTED THAT THE DARK BLUE END INSIDE THE TRANSFER SET IS UNGLUED AND COMING OUT OF THE TRANSFER SET AND THE POINTED END REMAINS IN THE PATIENT CONNECTION LINE. THIS OCCURRED DURING AN UNSPECIFIED PROCESS STEP OF PERITONEAL DIALYSIS 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
    1471926 AMIA AUTOMATED PD CYCLER SET SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE CORPORATION NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 TRANSFER SET