BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 10987446 · Received December 10, 2020

    Report

    Report Number
    1416980-2020-07700
    Event Type
    Malfunction
    Date Received
    December 10, 2020
    Report Date
    January 13, 2021
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    UDI-DI
    00085412007731
    PMA / PMN Number
    K192705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    H9: CORRECTION/REMOVAL REPORT NUMBER IS FA-2020-055. H10: THE DEVICE WAS RECEIVED FOR EVALUATION; HOWEVER, AN EVALUATION WAS NOT PERFORMED AS THIS ISSUE IS RELATED TO A FIELD ACTION. 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

    THIS OCCURRED ON AN UNSPECIFIED DATE IN 2020. 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 (SLEEVE) OF A MINICAP EXTENDED LIFE PD TRANSFER SET LEAKED; THIS WAS FURTHER DESCRIBED AS ¿HAD A LEAK COMING OUT OF WHITE PART OF TRANSFER SET¿. AS A RESULT, THE TRANSFER SET WAS REPLACED. THIS OCCURRED DURING USE OF THE DEVICE 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
    1448914 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION NA H20D30070 00085412007731

    Patients

    Seq Age Sex Outcome Treatment
    1 UNSPECIFIED PD SOLUTION