BEUDAMED
    FDA Adverse Event Death Summary report: N

    NURSE ASSIST, LLC

    MDR report key: 18475006 · Received January 9, 2024

    Report

    Report Number
    3002695476-2023-00039
    Event Type
    Death
    Date Received
    January 9, 2024
    Date of Event
    December 2, 2022
    Report Date
    December 28, 2023
    Manufacturer
    NURSE ASSIST, LLC
    Product Code
    FRO
    PMA / PMN Number
    K083042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MEDWATCH REPORTS MW5149038.

    Description of Event or Problem · 0

    ON 13-DEC-23, NURSE ASSIST RECEIVED A MEDWATCH REPORT VIA E-MAIL OF THE FOLLOWING EVENT DESCRIPTION FROM MEDWATCH REPORT: MY HUSBAND WAS DIAGNOSED WITH LARYNGEAL CANCER ON (B)(6) 2022 AND HAD A TRACH PLACED IMMEDIATELY IN THE ER(EMERGENCY ROOM) AT (B)(6). HE WAS TREATED FROM (B)(6) 2022 THROUGH (B)(6) 2022. HE WAS HOSPITALIZED 4 DIFFERENT TIMES AT MAYO FROM (B)(6) 2022 THROUGH (B)(6) 2023 FOR REPEATED INFECTIONS. DURING THIS TIME, I WAS HAVING TO CLEAN (B)(6)'S TRACH BY COMPLETELY REMOVING IT AND FLUSHING IT WITH SALINE WATER BEFORE REENTERING IT INTO HIS STOMA, RINSING THE INNER CANNULA, AND CLEANING AROUND HIS FEEDING TUBE WITH 0.9% SALINE SOLUTION AND SALINE WATER GIVEN TO ME FROM MAYO IN (B)(6). ALSO, I HAD TO ADMINISTER SALINE FLUSHES FOR IV INFUSIONS 3X A DAY FOR 9 DAYS EACH OF THOSE TIMES AT HOME 2 SEPARATE TIMES AFTER HOSPITALIZATION DUE TO BACTERIAL INFECTIONS. FIRST ADMINISTERED SALINE SYRINGE FLUSHES 10ML BEFORE AND AFTER IN HIS MIDLINE BEFORE ADMINISTERING CEFAZOLIN. THE SECOND TIME WAS 10ML BEFORE AND AFTER IN HIS MIDLINE BEFORE ADMINISTERING CEFEPIME. (B)(6) PASSED AWAY ON (B)(6) 2023, 3 DAYS AFTER HIS LAST HOSPITALIZATION. IT IS MY CONCERN THAT (B)(6) REPEATED BACTERIAL INFECTIONS MAY HAVE BEEN LINKED TO THE EXCESSIVE USE OF 0.9% CONTAMINATED SALINE SOLUTION AND SALINE WATER DURING THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589937 NURSE ASSIST, LLC 0.9% NORMAL SALINE FOR IRRIGATION USP IN SCREW BOTTLE TOP FRO NURSE ASSIST, LLC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| D