BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 3760085 · Received April 18, 2014

    Report

    Report Number
    1416980-2014-12699
    Event Type
    Malfunction
    Date Received
    April 18, 2014
    Report Date
    March 26, 2014
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MICROSCOPIC EXAMINATION WAS PERFORMED IN ADDITION TO A VISUAL INSPECTION WITH THE NAKED EYE. DAMAGE MARKINGS, INDICATIVE OF TOOL USE, WERE IDENTIFIED IN ADDITION TO THE MISSING CHIP. THE CAUSE WAS UNABLE TO BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS REPORTED TO BE AVAILABLE FOR EVALUATION, AND A REQUEST FOR ITS RETURN HAS BEEN MADE. A TREND REVIEW WILL BE CONDUCTED. IF SIMILAR REPORTS HAVE BEEN RECEIVED, BAXTER WILL CONTINUE TO MONITOR THEM IN ORDER TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO BAXTER AND THE EVALUATION IS COMPLETE. A VISUAL INSPECTION WAS PERFORMED WITH A CHIP MISSING FROM THE DARK BLUE CONNECTOR AND LIGHT BLUE MAIN BODY NOTED. A LEAK TEST WITH UNDER WATER PRESSING WAS PERFORMED. A CLAMP FUNCTION TEST AND CLEAR PASSAGE TEST WERE PERFORMED WITH NO ISSUES NOTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FEMALE CONNECTOR OF A MINICAP EXTEND LIFE PD TRANSFER SET WITH TWIST CLAMP SEPARATED FROM ITS MAIN BODY. THIS WAS IDENTIFIED AFTER PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236818 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1