BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMIA AUTOMATED PD CYCLER SET

    MDR report key: 11117592 · Received January 5, 2021

    Report

    Report Number
    1416980-2020-08306
    Event Type
    Malfunction
    Date Received
    January 5, 2021
    Date of Event
    September 9, 2020
    Report Date
    February 5, 2021
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    PMA / PMN Number
    K151525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION MADE TO D2B: CLASSIFICATION CODE: FKX (PREVIOUSLY SUBMITTED AS KDJ). H10: 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

    SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN AMIA DEVICE EXPERIENCED A LOW PRIORITY (MAX AIR EXCEEDED) ALARM. THE PATIENT WAS CONNECTED AT THE TIME OF THE ALARM. THIS OCCURRED DURING PATIENT INFUSION OF PERITONEAL DIALYSIS THERAPY. IT WAS FURTHER REPORTED THE PATIENT LINE CRACKED DUE TO "TOO MUCH PRESSURE"; THE TUBE SPLIT AND SUCKED IN AIR WHICH LED TO 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
    15391 AMIA AUTOMATED PD CYCLER SET SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE CORPORATION NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 AMIA AUTOMATED PD SYSTEM| AMIA AUTOMATED PD SYSTEM