BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACID DIALYSATE BATH

    MDR report key: 18369647 · Received December 20, 2023

    Report

    Report Number
    2150060-2023-00054
    Event Type
    Malfunction
    Date Received
    December 20, 2023
    Report Date
    December 20, 2023
    Manufacturer
    MEDIVATORS INC
    Product Code
    FKQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UDI RELATED DATA QUALITY UPDATES ONLY -THE MODEL/CATALOG NUMBER AND LOT/SERIAL NUMBER ARE UNKNOWN; THEREFORE, THE APPLICABLE UDI AND PRODUCTION IDENTIFIERS WERE NOT INCLUDED IN THE MDR.

    Additional Manufacturer Narrative · 0

    THE MEDWATCH REPORT MW5147611 DID NOT PROVIDE INITIAL REPORTER INFORMATION, SERIAL NUMBER, OR USER FACILITY NAME/ADDRESS. STERIS IS NOT THE MANUFACTURER OF THE DEVICE SUBJECT OF MEDWATCH MW5147611. STERIS HAS NOTIFIED THE MANUFACTURER, EVOQUA, TO INTERNALLY INVESTIGATE AND EVALUATE FOR REPORTABILITY IN ACCORDANCE WITH 21 CFR PART 803. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED VIA MEDWATCH MW5147611 THAT THE DIALYSATE SOLUTION WAS UTILIZED TO TREAT THE INCORRECT PATIENT FOR APPROXIMATELY 10 MINUTES. THE INTENDED PATIENT EXPERIENCED A DELAY IN PROCEDURE. FURTHER, THE USER HAD MIXED THE DIALYSATE SOLUTION BY HAND PER THE PRESCRIBER'S ORDER, BUT THERE WAS NO VERIFICATION OF THE CORRECT VALUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289471 ACID DIALYSATE BATH ACID DIALYSATE BATH FKQ MEDIVATORS INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown