BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NI

    MDR report key: 11959322 · Received June 8, 2021

    Report

    Report Number
    1416980-2021-03447
    Event Type
    Malfunction
    Date Received
    June 8, 2021
    Date of Event
    May 13, 2021
    Report Date
    July 8, 2021
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    PMA / PMN Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER RETURNED A DEVICE WHICH WAS IDENTIFIED TO HAVE A CATALOGUE # OF 5C4483, BRAND NAME OF MINICAP TRANSFER SET AND A 510K # OF K192705. H10: THE DEVICE WAS RECEIVED FOR EVALUATION WITH A PATIENT CONNECTOR ATTACHED TO THE FEMALE CONNECTOR. A VISUAL INSPECTION WITH THE NAKED EYE NOTED THE FEMALE CONNECTOR WAS SEPARATED FROM THE MAIN BODY. THERE WAS EVIDENCE ON THE FEMALE CONNECTOR AN INSERT CHIP WAS PRESENT. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE SEPARATION WAS DUE TO INADEQUATE SOLVENT APPLICATION DURING MANUFACTURING. A NONCONFORMANCE HAS BEEN OPENED TO ADDRESS THIS ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED AND IS CURRENTLY AWAITING EVALUATION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FEMALE CONNECTOR OF A PERITONEAL DIALYSIS (PD) TRANSFER SET UNSCREWED FROM THE MAIN BODY WHICH RESULTED IN THE CUSTOMER BEING UNABLE TO DISCONNECT FROM THE CYCLER. THIS EVENT OCCURRED AFTER PD THERAPY WAS COMPLETE AND THE PATIENT WAS ATTEMPTING TO DISCONNECT FROM THE CYCLER. TO RESOLVE THIS ISSUE, THE TRANSFER SET WAS REPLACED. 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
    859336 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 CYCLER