BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMIA AUTOMATED PD CYCLER SET

    MDR report key: 10771081 · Received November 2, 2020

    Report

    Report Number
    1416980-2020-06784
    Event Type
    Malfunction
    Date Received
    November 2, 2020
    Report Date
    November 25, 2020
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    PMA / PMN Number
    K151525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION MADE TO D2B: CLASSIFICATION CODE: FKX (PREVIOUSLY SUBMITTED AS KDJ) ADDITIONAL INFORMATION: H3 AND H6. H10: THE ACTUAL DEVICES WERE NOT AVAILABLE; HOWEVER, TWO (2) PHOTOGRAPHS OF THE SAMPLES WERE PROVIDED FOR EVALUATION. THE PHOTOGRAPHS WERE VISUALLY INSPECTED WHICH OBSERVED A LOOSE GREEN CAP TO THE PATIENT CONNECTOR. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE REPORTED CONDITION COULD NOT BE DETERMINED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER ADDRESS - (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE GREEN PROTECTIVE PATIENT LINE CAPS OF AN UNSPECIFIED QUANTITY OF AMIA AUTOMATED PD CYCLER SETS WERE DISCONNECTING. THE PROTECTIVE PATIENT LINE CAPS WOULD FALL OFF THE PATIENT LINE DURING UNSPECIFIED PROCESS STEPS 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
    1234152 AMIA AUTOMATED PD CYCLER SET SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE CORPORATION NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1