BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMIA AUTOMATED PD CYCLER SET

    MDR report key: 10423086 · Received August 18, 2020

    Report

    Report Number
    1416980-2020-05063
    Event Type
    Malfunction
    Date Received
    August 18, 2020
    Date of Event
    July 24, 2020
    Report Date
    August 18, 2020
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    PMA / PMN Number
    K151525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RED CLAMP LINE OF AN AMIA CASSETTE DISCONNECTED FROM A SUPPLY BAG. THIS WAS IDENTIFIED DURING THE PRIME STAGE OF PERITONEAL DIALYSIS THERAPY. THE PATIENT INDICATED THE CONNECTION ON THE RED CLAMP WAS PROPERLY TIGHTENED PRIOR TO THE START OF THERAPY. RENAL THERAPY SERVICES (RTS) ADVISED THE PATIENT TO START OVER WITH NEW SUPPLIES AND DISCUSSED CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD) 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
    885731 AMIA AUTOMATED PD CYCLER SET SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE CORPORATION NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1