BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 3892452 · Received June 24, 2014

    Report

    Report Number
    1416980-2014-20139
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Date of Event
    May 24, 2014
    Report Date
    June 4, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A USED PATIENT SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION PERFORMED WITH NAKED EYE AND CLEMEX INTELLIGENT MICROSCOPE IDENTIFIED A DAMAGED/MISSING CHIP. LEAK TESTING, CLEAR PASSAGE TESTING, AND CLAMP FUNCTION TESTING WERE PERFORMED WITH NO ISSUES NOTED. THE REPORTED ISSUE WAS VERIFIED. THE LOT NUMBER OF THE DEVICE WAS UNKNOWN; THEREFORE, A BATCH REVIEW COULD NOT BE COMPLETED. UPON CONCLUSION OF THE INVESTIGATION, THE CAUSE OF THE EVENT WAS DETERMINED TO BE A MANUFACTURING ISSUE. A CAPA WAS OPENED TO INVESTIGATE THIS ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS (PD) NURSE REPORTED THAT THE PATIENT COULD NOT DISCONNECT A SOLUTION BAG FROM A TRANSFER SET WHEN SETTING UP DIALYSIS. THE PD NURSE ASSISTED THE PATIENT IN REPLACING THE TRANSFER SET. THE TRANSFER SET WAS USED ON THE PATIENT IN THE MONTH OF THIS REPORT. WHILE THERE WAS PATIENT INVOLVEMENT, THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367642 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN PERITONEAL DIALYSIS SOLUTION BAG