BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NI

    MDR report key: 12316135 · Received August 12, 2021

    Report

    Report Number
    1416980-2021-04975
    Event Type
    Malfunction
    Date Received
    August 12, 2021
    Date of Event
    July 16, 2021
    Report Date
    September 14, 2021
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    PMA / PMN Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: H3, H6, H10. THE RETURNED SAMPLE WAS IDENTIFIED AS FOLLOWS: D4: CATALOGUE # OF 5C4482, D1: BRAND NAME OF MINICAP TRANSFER SET, AND G4: PMA/510K # OF K152675. H10: THE SAMPLE WAS RECEIVED FOR EVALUATION WITH NO CAP. A VISUAL INSPECTION WITH THE NAKED EYE NOTED BROKEN OCCLUDER LEGS. THE BROKEN OCCLUDER LEGS WOULD RESULT IN THE CLAMP MECHANISM NOT FUNCTIONING; THE FLUID FLOW WOULD NOT BE SHUT OFF. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE BROKEN OCCLUDER LEGS COULD NOT BE DETERMINED. A NONCONFORMANCE HAS BEEN OPENED TO ADDRESS THIS ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER ADDRESS: (B)(6). THE DEVICE HAS BEEN RECEIVED AND THE EVALUATION IS IN PROGRESS. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TWIST CLAMP OF THE MINICAP TRANSFER SET LEAKED; FURTHER DESCRIBED AS "THE WHITE PIECE BROKE AWAY FROM THE BLUE PART AND WAS JUST SPINNING AROUND. THERE WAS FLUID LEAKING OUT". THIS OCCURRED WHILE CAPPING THE PATIENT OFF AFTER PERITONEAL DIALYSIS 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
    1213328 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1