BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 18152814 · Received November 16, 2023

    Report

    Report Number
    1416980-2023-05978
    Event Type
    Malfunction
    Date Received
    November 16, 2023
    Report Date
    December 20, 2023
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    PMA / PMN Number
    K192705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS ADDED TO B5, D9, H3, H6 AND H10. B5: THE ISSUE WAS FURTHER DESCRIBED AS THE ¿THE BREAK IN THE TRANSFER SET WAS INSIDE THE WHITE TWIST CLAMP IN THE TRANSFER SET. A PRONG INSIDE APPARENTLY BROKE AND ALLOWED TWIST CLAMP TO UNSCREW COMPLETELY¿. H10: THE SAMPLE WAS RECEIVED FOR EVALUATION WITH A MINICAP ATTACHED TO THE FEMALE CONNECTOR. A VISUAL INSPECTION WITH THE NAKED EYE NOTED A BROKEN OCCLUDER FOOT BENEATH THE TWIST CLAMP. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE CONDITION COULD NOT BE DETERMINED; HOWEVER, EXPOSURE TO CHEMICAL AGENTS SUCH AS HYDROGEN PEROXIDE, ALCOHOL OR BLEACH, AS LISTED ON PRODUCT PACKAGING, CAN DAMAGE THE TRANSFER SET MATERIALS. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    B3/D10: THE EVENT OCCURRED FROM OCTOBER 16, 2023 - OCTOBER 17, 2023. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TWIST CLAMP OF THE MINICAP TRANSFER SET BROKE. THIS WAS OBSERVED DURING USE OF THE DEVICE FOR PERITONEAL DIALYSIS THERAPY. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT, HOWEVER THE PATIENT WAS TREATED WITH VANCOMYCIN 1 GM IP (INTRAPERITONEAL) X 6 HR DWELL AND CEFEPIME 1 GM IP X 6 HR DWELL ONE TIME. ALCAVIS HAD BEEN USED ON THE TRANSFER SET. THE TRANSFER SET WAS REPLACED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    907409 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown NI.