BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 15945863 · Received December 8, 2022

    Report

    Report Number
    1416980-2022-06755
    Event Type
    Malfunction
    Date Received
    December 8, 2022
    Date of Event
    November 9, 2022
    Report Date
    December 8, 2022
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    UDI-DI
    00085412030531
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 0

    A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE DEVICE WAS NOT RECEIVED FOR EVALUATION; 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 · 0

    IT WAS REPORTED THAT A HOMECHOICE CASSETTE LEAKED FROM AN UNKNOWN LOCATION. THIS WAS OBSERVED WHILE THE CLARIA DEVICE WAS TURNED OFF AND "NOT WORKING. THE LEAK WAS FURTHER DESCRIBED AS ¿LIQUID ON THE SHELF OF THE CABINET UNDER THE CLARIA¿. 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
    445090 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE CORPORATION NA S22F15055 00085412030531

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown CLARIA DEVICE.| UNSPECIFIED SOLUTION.