BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 10635344 · Received October 6, 2020

    Report

    Report Number
    1416980-2020-06220
    Event Type
    Malfunction
    Date Received
    October 6, 2020
    Report Date
    October 8, 2020
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    PMA / PMN Number
    K192705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    D4: CATALOGUE #: 5C4482 (REMOVE 5C4484). G5: PMA/510K #: K192705 (REMOVE K851207). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE EVENTS OCCURRED ON AN UNSPECIFIED DATE REPORTED AS "THIS YEAR" (2020). THE DEVICES WERE NOT RETURNED AND THE LOT NUMBERS ARE UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THREE (3) UNITS OF MINICAP EXTENDED LIFE PD TRANSFER SETS BECAME DISCONNECTED FROM THE TITANIUM ADAPTER; FURTHER DESCRIBED AS THE ¿TRANSFER SETS FALL OFF¿. THIS OCCURRED WHILE IN USE ON A PATIENT DURING UNSPECIFIED PROCESS STEPS OF PERITONEAL DIALYSIS THERAPY. THE TITANIUM ADAPTER REMAINED IN USE. 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
    1103799 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 TITANIUM ADAPTER| TITANIUM ADAPTER