BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP

    MDR report key: 19407388 · Received May 28, 2024

    Report

    Report Number
    1416980-2024-02547
    Event Type
    Malfunction
    Date Received
    May 28, 2024
    Date of Event
    May 2, 2024
    Report Date
    June 28, 2024
    Manufacturer
    BAXTER INTERNATIONAL INC.
    Product Code
    KDJ
    UDI-DI
    00085412007748
    PMA / PMN Number
    K192705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION D1, D3, D4, G4. D1: BRAND NAME: REPLACE MINICAP TRANSFER SET WITH MINICAP. D3: DEVICE MANUFACTURE NAME: REPLACE BAXTER HEALTHCARE CORPORATION WITH BAXTER INTERNATIONAL INC. D4: UNIQUE IDENTIFIER (UDI) #: REPLACE NI WITH (B)(4); THE LOT NUMBER IS UNKNOWN, THEREFORE, ONLY A PRIMARY DI NUMBER COULD BE PROVIDED. G4: COMBINATION PRODUCT: ADD NO (PREVIOUSLY BLANK). ADDITIONAL INFORMATION WAS RECEIVED FOR D9, H3, H6, AND H11. H11: THE ACTUAL SAMPLE WAS RETURNED FOR EVALUATION. THE SAMPLE WAS RETURNED WET WITH A PATIENT CONNECTOR ATTACHED TO THE FEMALE CONNECTOR. A VISUAL INSPECTION OBSERVED A SEPARATION BETWEEN THE FEMALE CONNECTOR AND THE MAIN BODY OF THE TWIST CLAMP. THERE IS EVIDENCE AN INSERT CHIP WAS PRESENT ON THE DARK BLUE FEMALE CONNECTOR. FUNCTIONAL CLEAR PASSAGE AND CLAMP FUNCTION TESTS WERE PERFORMED WITH NO ISSUES NOTED. THE SAMPLE WAS ALSO CONNECTED AND DISCONNECTED BY HAND USING THE RETURNED PATIENT CONNECTOR WITH NO ISSUES AND NO LEAKS OBSERVED. THE REPORTED CONDITION OF THE CONNECTION ISSUE TO THE FEMALE CONNECTOR WAS NOT VERIFIED, HOWEVER THE REPORTED CONDITION WAS SEPARATION WAS VERIFIED. THE CAUSE WAS DETERMINED TO BE A MANUFACTURING RELATED ISSUE CAUSED BY INADEQUATE SOLVENT TO THE INSERT CHIP. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A MINICAP TRANSFER SET WOULD NOT COME APART FROM THE PATIENT LINE TUBING OF THE AMIA CASSETTE AND WAS COMING APART FROM THE LIGHT BLUE PORTION. THIS OCCURRED AFTER USE OF THE DEVICES FOR PERITONEAL DIALYSIS (PD) THERAPY. 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
    311622 MINICAP SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER INTERNATIONAL INC. NA ASKU 00085412007748

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown AMIA CASSETTE