BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 17329979 · Received July 14, 2023

    Report

    Report Number
    1416980-2023-03578
    Event Type
    Malfunction
    Date Received
    July 14, 2023
    Date of Event
    June 17, 2023
    Report Date
    August 21, 2023
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    PMA / PMN Number
    K192705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION D1, D4, G4 (OMITTED ON INITIAL REPORT). D1: BRAND NAME: ADD: MINICAP TRANSFER SET (REMOVE NI). D4: CATALOGUE #: ADD: 5C4483 (REMOVE ASKU). G4: 510K #: ADD: K192705 (REMOVE NI). H10: THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    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 CONNECTION ISSUE WITH THE PATIENT LINE OF A HOMECHOICE LOW RECIRCULATION VOLUME APD SET AND TRANSFER SET WHICH RESULTED IN A LEAK. THE CONNECTION ISSUE WAS FURTHER DESCRIBED AS, ¿PATIENT CONNECTOR JOINTS IN CASSETTES ARE DETACHED AND HAVE BEEN FOUND TO BE DETACHED DURING MACHINE USE¿. THIS OCCURRED DURING USE OF THE DEVICES FOR 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
    693200 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown HOMECHOICE APD SET WITH CASSETTE