BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 17367374 · Received July 20, 2023

    Report

    Report Number
    1416980-2023-03683
    Event Type
    Malfunction
    Date Received
    July 20, 2023
    Date of Event
    May 27, 2023
    Report Date
    August 23, 2023
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    PMA / PMN Number
    K192705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4: CATALOGUE #: (REMOVE 5C4482) AND UPDATE TO 5C4483. G4: PMA/510K#: (REMOVE K152675) AND UPDATE TO K192705. H10: THE DEVICE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION WITH THE NAKED EYE IDENTIFIED A BROKEN OCCLUDER FOOT ON THE LIGHT BLUE MAIN BODY OF THE TWIST CLAMP. FUNCTIONAL TESTING INCLUDING LEAK, CLEAR PASSAGE AND CLAMP FUNCTION TESTING WERE PERFORMED. NO ISSUES WERE NOTED DURING THE CLEAR PASSAGE TEST. THE LEAK AND CLAMP FUNCTION TESTS REVEALED A LEAK DURING TESTING WITH THE TWIST CLAMP IN THE CLOSED POSITION.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. A NONCONFORMANCE HAS BEEN OPENED TO ADDRESS THIS ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    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 · 0

    IT WAS REPORTED THAT A MINICAP EXTENDED LIFE PD TRANSFER SET HAD FLUID FLOW WITH THE TWIST CLAMP CLOSED; FLUID LEAKED OUT OF THE NAVY-BLUE (FEMALE CONNECTOR) END. THIS WAS OBSERVED AFTER A MANUAL EXCHANGE, AFTER CLOSING THE SET. THE TRANSFER SET WAS REPLACED. 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
    1704824 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown