BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CADD LEGACY

    MDR report key: 14775815 · Received June 21, 2022

    Report

    Report Number
    MW5110410
    Event Type
    Injury
    Date Received
    June 21, 2022
    Date of Event
    June 1, 2022
    Report Date
    June 16, 2022
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    LHI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT REPORTS AN EMERGENCY ROOM VISIT WHERE SHE HAD TO BE ADMITTED FOR 24 HOURS DUE TO HEART FAILURE. PATIENT STATED THAT ONE OF HER REMODULIN VIALS(PATIENT DISCARDED VIAL) HAD A BAD STOPPER AND THE MEDICATION WOULD LEAK OUT AS SHE WOULD FILL HER SYRINGE. PATIENT FEELS AS THOUGH THE MEDICATION LOST ITS POTENCY DUE TO THE BAD STOPPER SO SHE WASN'T GETTING HER FULL DOSE. WHEN PATIENT MIXED A CASSETTE USING NEW VIAL OF REMODULIN PATIENT WAS UNABLE TO TOLERATE THE MEDICATION AND HAD TO REDUCE HER DOSE. PATIENT WAS THEN UNABLE TO INCREASE BACK TO HER PREVIOUS DOSE DUE TO DIARRHEA. PATIENT HAD MD APPOINTMENT TODAY. PATIENT THINKS THE MD WOULD LIKE HER TO BE ABLE TO INCREASE TO PREVIOUS DOSE BUT SHE CAN'T DUE TO DIARRHEA. PATIENT REPORTS PUMP SN (B)(4) ALARMS FREQUENTLY SO SHE HAS ONLY BEEN USING ONE PUMP, AUTHOR ADVISED WE WOULD SET UP ORDER FOR REPLACEMENT PUMP FOR EARLY AM DELIVERY. NO ADDITIONAL INFORMATION. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1400769 CADD LEGACY PUMP, INFUSION LHI SMITHS MEDICAL ASD, INC. 6400
    1400770 REMODULIN VIAL SET, I.V. FLUID TRANSFER LHI UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female Hospitalization REMODULIN