BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NI

    MDR report key: 14516112 · Received May 26, 2022

    Report

    Report Number
    1416980-2022-02664
    Event Type
    Malfunction
    Date Received
    May 26, 2022
    Date of Event
    April 28, 2022
    Report Date
    June 22, 2022
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    PMA / PMN Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RECEIVED AND IS CURRENTLY AWAITING EVALUATION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION IN H3, H6 AND H10. THE RETURNED SAMPLE HAS A D1: BRAND NAME OF MINICAP TRANSFER SET, A D4: CATALOGUE # OF 5C4482, AND G4: PMA/510K # OF K152675. H10: THE DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION WITH THE NAKED EYE AND MAGNIFICATION DID NOT IDENTIFY ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. FUNCTIONAL TESTING INCLUDING LEAK, CLEAR PASSAGE AND CLAMP FUNCTION TESTING WERE PERFORMED WITH NO ISSUES NOTED. THE REPORTED CONDITION WAS NOT VERIFIED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A DISCONNECTION BETWEEN THE MINICAP EXTENDED LIFE PD TRANSFER SET AND THE PATIENT LINE OF AN AMIA AUTOMATED PD SET WHICH RESULTED IN LEAK. THIS EVENT WAS FURTHER DESCRIBED AS ¿PATIENT WOKE UP AND FELT WET" AND NOTICED THE "WHOLE TRANSFER SET WAS COMPLETELY OFF". THIS OCCURRED DURING USE FOR AUTOMATED PERITONEAL DIALYSIS THERAPY. THE PATIENT WAS GIVEN VANCOMYCIN AS A PRECAUTIONARY MEASURE. 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
    2769048 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown AMIA AUTOMATED PD CYCLER SET