BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP CADD LEGACY

    MDR report key: 12657968 · Received October 18, 2021

    Report

    Report Number
    MW5104700
    Event Type
    Injury
    Date Received
    October 18, 2021
    Date of Event
    April 30, 2021
    Report Date
    May 1, 2021
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    LHI
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    SPONTANEOUS REPORT FROM PATIENT STATING HIS CENTRAL LINE RIPPED OUT LAST NIGHT ((B)(6) 2021) AND HE WENT INTO HOSPITAL ((B)(6) MEDICAL CENTER). PATIENT WAS OFF VELETRI FOR AN UNKNOWN AMOUNT OF TIME, NO HARM DONE TO PATIENT. NO DEVICE REPLACEMENT NEEDED, PUMP DID NOT MALFUNCTION. PATIENT REPORTED AFTER PRODUCT FAULT OCCURRED MEDICAL INTERVENTION PROVIDED IN HOSPITAL. PATIENT DID NOT START INFUSION AGAIN AT HOME, WENT TO HOSPITAL AND IS STABLE. LINE REPLACEMENT TOMORROW ((B)(6) 2021). CNSS IS BRINGING SUPPLIES TO PATIENT SO HE CAN BE DISCHARGED FROM HOSPITAL. INFUSION IS LIFE-SUSTAINING. EVENT IS ONGOING. NO FURTHER INFORMATION. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1550110 PUMP CADD LEGACY SET, I.V. FLUID TRANSFER LHI SMITHS MEDICAL ASD, INC. 6400

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization