BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMIA AUTOMATED PD SET WITH CASSETTE

    MDR report key: 19778063 · Received July 18, 2024

    Report

    Report Number
    1416980-2024-03720
    Event Type
    Malfunction
    Date Received
    July 18, 2024
    Date of Event
    June 28, 2024
    Report Date
    August 27, 2024
    Manufacturer
    BAXTER INTERNATIONAL INC
    Product Code
    FKX
    UDI-DI
    00085412153186
    PMA / PMN Number
    K151525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    CORRECTION D3: DEVICE MANUFACTURER NAME: REPLACE BAXTER HEALTHCARE CORPORATION WITH BAXTER INTERNATIONAL INC H11: A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE DEVICE WAS DISCARDED; 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 · 0

    IT WAS REPORTED AN AMIA AUTOMATED PD CYCLER SET LEAKED FROM AN UNKNOWN LOCATION. THE EVENT OCCURRED DURING AN UNKNOWN PROCESS STEP FOR PERITONEAL DIALYSIS (PD) THERAPY. THERE WAS NO REPORT OF 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
    1646123 AMIA AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER INTERNATIONAL INC NA H24D08098 00085412153186

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown AMIA DEVICE| UNKNOWN PD SOLUTION