BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEGACY PUMP

    MDR report key: 13839996 · Received March 18, 2022

    Report

    Report Number
    MW5108342
    Event Type
    Malfunction
    Date Received
    March 18, 2022
    Date of Event
    March 17, 2022
    Report Date
    March 17, 2022
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    LHI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SPONTANEOUS CALL FORM PATIENT TO REPORT HER PUMP SAID 'NO DISPOSABLE' ERROR WHICH HAS HAPPENED IN THE PAST. SHE SWITCHED TO HER BACK UP PUMP AND WAS INFUSING JUST FINE. SHE DID NOT WANT PUMP REPLACED AND THINKS MORE THAN LIKELY THIS IS NOT A PUMP ISSUE BUT A CASSETTE ISSUE- SHE PROVIDED CASSETTE LOT# 4220003. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35925 LEGACY PUMP PUMP, INFUSION LHI SMITHS MEDICAL ASD, INC. UNK
    35926 CASSETTE MEDI RESERVOIR SET, I.V. FLUID TRANSFER LHI SMITHS MEDICAL ASD, INC. 4220003

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female