BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEX

    MDR report key: 11054671 · Received December 22, 2020

    Report

    Report Number
    1641965-2020-00024
    Event Type
    Malfunction
    Date Received
    December 22, 2020
    Date of Event
    December 9, 2020
    Report Date
    January 26, 2021
    Manufacturer
    B. BRAUN MEDICAL INC.
    Product Code
    NEP
    UDI-DI
    04046955048502
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INC. INTERNAL REPORT NUMBER (B)(4). THE LOGS WERE PROVIDED FOR EVALUATION. THE LOGS SHOW THAT SODIUM PHOSPHATE WAS CONFIRMED ON STATION 20 AND LATER A POTASSIUM PHOSPHATE NDC WAS SCANNED AND CONFIRMED ON STATION 20. IT WAS FOUND THAT THE TWO (2) SOLUTIONS WERE MARKED AS INTERCHANGEABLE IN THE DATABASE. APEX WILL ALLOW SOLUTIONS THAT ARE MARKED INTERCHANGEABLE TO BE SWITCHED ON THE SAME STATION THROUGHOUT THE DAY AND WHEN RECONCILING AN ORDER WOULD ALLOW THE ORDERED VOLUME TO BE FILLED BY EITHER INTERCHANGEABLE INGREDIENT. TO FIX THIS, THE USER NEEDS TO GO INTO EITHER THE SODIUM PHOSPHATE INGREDIENT OR THE POTASSIUM PHOSPHATE INGREDIENT AND UNDO THE INTERCHANGEABILITY BETWEEN THE TWO. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE A FOLLOW-UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INC. INTERNAL REPORT NUMBER: (B)(4). THE INVESTIGATION IS ONGOING AT THIS TIME. A FOLLOW UP WILL BE SUBMITTED WHEN THE INVESTIGATION RESULTS BECOME AVAILABLE.

    Description of Event or Problem · 1

    AS PER REPORTED BY THE USER FACILITY: THE SOLUTION ON LINE 20 CHANGED FROM SODIUM PHOSPHATE TO POTASSIUM PHOSPHATE IN THE APEX SYSTEM. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1519572 APEX COMPOUNDER NEP B. BRAUN MEDICAL INC. AX1000 04046955048502

    Patients

    Seq Age Sex Outcome Treatment
    1