BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NI

    MDR report key: 13563811 · Received February 18, 2022

    Report

    Report Number
    1416980-2022-00622
    Event Type
    Malfunction
    Date Received
    February 18, 2022
    Date of Event
    January 25, 2022
    Report Date
    March 21, 2022
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    PMA / PMN Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    H10: BASED ON THE RETURNED DEVICE, THE D4 CATALOGUE # IS 5C4483, D1 BRAND NAME IS MINICAP TRANSFER SET, AND G4 510K # IS K192705. THE DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION WITH THE NAKED EYE AND WITH MAGNIFICATION DID NOT IDENTIFY ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. FUNCTIONAL TESTING INCLUDING LEAK, CLEAR PASSAGE, CLAMP FUNCTION, AND INTEGRITY OF SEAL SURFACE TESTING WAS PERFORMED WITH NO ISSUES NOTED; THERE WERE NO ISSUES WITH CONNECTION/DISCONNECTIONS DURING TESTING. 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 A HOME PATIENT EXPERIENCED A CONNECTION ISSUE BETWEEN THE PATIENT CONNECTOR OF THE TRANSFER SET AND THE TITANIUM ADAPTER. THE CONNECTION ISSUE WAS FURTHER DESCRIBED AS THE TRANSFER SET DISCONNECTING FROM THE TITANIUM ADAPTER. THIS OCCURRED DURING USE OF THE DEVICE FOR PERITONEAL DIALYSIS THERAPY. THERE WAS NO ALLEGATION AGAINST THE TITANIUM ADAPTER AND THE ADAPTER WAS STILL IN USE. 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
    1196956 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown TITANIUM ADAPTER