BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMIA AUTOMATED PD CYCLER SET

    MDR report key: 18717211 · Received February 15, 2024

    Report

    Report Number
    1416980-2024-00596
    Event Type
    Malfunction
    Date Received
    February 15, 2024
    Date of Event
    January 22, 2024
    Report Date
    April 25, 2024
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    PMA / PMN Number
    K151525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION MADE TO A1: PATIENT IDENTIFIER: (B)(6) (PREVIOUSLY SUBMITTED AS UNKNOWN) CORRECTION MADE TO B5: IT WAS REPORTED THAT THE PATIENT LINE OF THE AMIA (PREVIOUSLY SUBMITTED AS HOMECHOICE) CASSETTE WAS UNABLE TO BE DISCONNECTED FROM THE TRANSFER SET. CORRECTION MADE TO D1: BRAND NAME: AMIA AUTOMATED PD CYCLER SET (PREVIOUSLY SUBMITTED AS NI). CORRECTION MADE TO D4: CATALOGUE #: 5C5479 (PREVIOUSLY SUBMITTED AS ASKU). CORRECTION MADE TO G4: PMA/510K # OR BLA #: K151525 (PREVIOUSLY SUBMITTED AS NI). ADDITIONAL INFORMATION WAS ADDED TO D9, G1, H3, H6, AND H10: H10: THE DEVICE WAS RECEIVED FOR EVALUATION ATTACHED TO THE TRANSFER SET. THE RETURNED PATIENT CONNECTOR WAS REMOVED BY HAND FROM THE FEMALE CONNECTOR OF THE TRANSFER SET WITH NO ISSUES. THE REPORTED CONDITION WAS NOT VERIFIED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    G1 MANUFACTURING FACILITY - THIS DEVICE WAS MANUFACTURED AT ONE OF THE TWO FOLLOWING MANUFACTURING SITES: BAXTER HEALTHCARE - MOUNTAIN HOME 1900 N HIGHWAY 201 MOUNTAIN HOME, AR 72653 UNITED STATES BAXTER HEALTHCARE - DOMINICAN REPUBLIC CARRETERA SANCHEZ KM 18.5, PARQUE INDUSTRIAL ITABO, PIISA HAINA, SAN CRISTOBAL 91000 DOMINICAN REPUBLIC 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 · 0

    IT WAS REPORTED THAT THE PATIENT LINE OF THE HOMECHOICE CASSETTE WAS UNABLE TO BE DISCONNECTED FROM THE TRANSFER SET. THIS WAS OBSERVED DURING USE OF PERITONEAL DIALYSIS 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
    1000108 AMIA AUTOMATED PD CYCLER SET SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE CORPORATION NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown TRANSFER SET