BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 14323680 · Received May 7, 2022

    Report

    Report Number
    1416980-2022-02307
    Event Type
    Malfunction
    Date Received
    May 7, 2022
    Date of Event
    March 21, 2022
    Report Date
    June 10, 2022
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    UDI-DI
    00085412007748
    PMA / PMN Number
    K152675
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    D4: CATALOGUE #: WAS CHANGED FROM 5C4483 TO 5C4482. D4: LOT #: WAS CHANGED FROM H21H31052 TO ASKU. G4: PMA/510K # OR BLA #: WAS CHANGED FROM K192705 TO K152675. H10: THE SAMPLE WAS RECEIVED FOR EVALUATION WITH THE WHITE TWIST CLAMP WAS IN CLOSED POSITION. A VISUAL INSPECTION WITH THE NAKED EYE AND MAGNIFICATION NOTED THE SILICONE TUBING WAS TORN OR BROKEN IN BETWEEN THE OCCLUDE LEGS AND ONE OF THE OCCLUDE FEET WAS BROKE. FUNCTIONAL TESTING INCLUDING LEAK TESTING, CLEAR PASSAGE TESTING, AND CLAMP FUNCTION TESTING WERE PERFORMED; LEAK TESTING AND CLAMP FUNCTION TESTING FAILED DUE TO THE SET LEAKED AT THE TORN OR BROKEN SILICONE TUBING AND AT THE TWIST CLAMP IN CLOSED POSITION. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE CONDITION COULD NOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A SEPARATION BETWEEN THE FEMALE CONNECTOR (DARK BLUE PART) AND MAIN BODY OF A MINICAP EXTENDED LIFE PD TRANSFER SET. THIS WAS OBSERVED AFTER GIVING THE PATIENT TISSUE PLASMINOGEN ACTIVATOR (TPA); THE NURSE PERFORMED A FLUSH AND WAS DISCONNECTING THE SYRINGE. THIS WAS FURTHER DESCRIBED AS ¿THE DARK BLUE PART OF THE TRANSFER SET UNTWISTED WITH THE SYRINGE AND THE DARK BLUE PART CAME APART FROM ITS BASE¿. THE TRANSFER SET WAS REPLACED. THERE WAS NO PATIENT INJURY; HOWEVER, THE PATIENT WAS GIVEN UNSPECIFIED MEDICATION AS A PRECAUTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1067455 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION NA H21H31052 00085412007748

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown TPA| UNSPECIFIED SYRINGE