BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 10657170 · Received October 9, 2020

    Report

    Report Number
    1416980-2020-06314
    Event Type
    Malfunction
    Date Received
    October 9, 2020
    Date of Event
    September 1, 2020
    Report Date
    November 10, 2020
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    UDI-DI
    00085412007731
    PMA / PMN Number
    K192705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION MADE TO G5: PMA/510K: K192705 (PREVIOUSLY SUBMITTED AS 5C4482). H10: THE DEVICE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED WITH THE NAKED EYE NOTED A CRACK IN THE LIGHT BLUE MAINBODY. FUNCTIONAL TESTING INCLUDING LEAK, CLEAR PASSAGE, AND CLAMP FUNCTION TESTING WERE PERFORMED WITH NO ISSUES NOTED. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE REPORTED CONDITION COULD NOT BE DETERMINED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED AND IS CURRENTLY AWAITING EVALUATION. 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 A PERITONEAL DIALYSIS (PD) TRANSFER SET WAS CRACKED. THE CRACKED TWIST CLAMP WAS DISCOVERED WITHIN ONE WEEK OF USING THE TRANSFER SET FOR 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
    1123134 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION NA H19J01031 00085412007731

    Patients

    Seq Age Sex Outcome Treatment
    1 NI.