BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NI

    MDR report key: 14047337 · Received April 7, 2022

    Report

    Report Number
    1416980-2022-01655
    Event Type
    Malfunction
    Date Received
    April 7, 2022
    Date of Event
    March 14, 2022
    Report Date
    May 12, 2022
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    PMA / PMN Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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

    BASED ON THE RETURNED DEVICE, THE CATALOGUE # IS 5C4482, THE BRAND NAME IS MINICAP TRANSFER SET, WHICH HAS A 510K # OF K152675. H10: THE SAMPLE WAS RECEIVED FOR EVALUATION WITH A PATIENT CONNECTOR ATTACHED TO FEMALE CONNECTOR. A VISUAL INSPECTION WITH THE NAKED EYE NOTED THAT THE FEMALE CONNECTOR WAS SEPARATED FROM THE MAIN BODY. FUNCTIONAL TESTING, INCLUDING LEAK, CLEAR PASSAGE AND CLAMP FUNCTION TESTING WERE PERFORMED WITH NO ISSUES NOTED. THE CONNECTION/DISCONNECTION BETWEEN THE FEMALE CONNECTOR AND PATIENT CONNECTOR WERE PERFORMED WITH NO ISSUES NOTED. THE REPORTED CONNECTION ISSUE WAS NOT VERIFIED AT THE FEMALE CONNECTOR. HOWEVER, A SEPARATION OF THE FEMALE CONNECTOR FROM THE MAINBODY WAS VERIFIED. THE CAUSE OF THE SEPARATION WAS DUE TO INADEQUATE SOLVENT APPLICATION DURING MANUFACTURING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DARK BLUE FEMALE CONNECTOR OF A PERITONEAL DIALYSIS (PD) TRANSFER SET WAS UNABLE TO DISCONNECT FROM THE PATIENT LINE OF THE HOMECHOICE CASSETTE. THIS WAS OBSERVED WHILE DISCONNECTING FROM PERITONEAL DIALYSIS (PD) THERAPY. TO RESOLVE THIS ISSUE, THE TRANSFER SET WAS REPLACED. 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
    939331 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Male HOMECHOICE CASSETTE