BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 17682815 · Received September 5, 2023

    Report

    Report Number
    1416980-2023-04453
    Event Type
    Malfunction
    Date Received
    September 5, 2023
    Date of Event
    August 9, 2023
    Report Date
    October 6, 2023
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    UDI-DI
    00085412008776
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION MADE TO D4: EXPIRATION DATE: 07/05/2027 (PREVIOUSLY SUBMITTED AS NI). H10: THE DEVICE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION WITH THE NAKED EYE NOTED A BROKEN OCCLUDE FEET ON THE LIGHT BLUE MAIN BODY. FUNCTIONAL TESTING INCLUDING LEAK TESTING, CLEAR PASSAGE TESTING, AND CLAMP FUNCTION TESTING WERE PERFORMED; LEAK TESTING AND CLAMP FUNCTION TESTING IDENTIFIED A LEAK WITH THE TWIST CLAMP CLOSED. 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. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    A 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 THERE WAS UNRESTRICTED FLUID FLOW THROUGH A PERITONEAL DIALYSIS (PD) TRANSFER SET WITH THE TWIST CLAMP IN CLOSED POSITION. THE EVENT WAS FURTHER DESCRIBED AS ¿THE LIQUID WAS COMING OUT DESPITE HAVING THE EXTENSION WAS CLOSED AND THE STOPPER ON¿. 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
    1560033 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION NA H22G05073 00085412008776

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown