BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CADD LEGACY PUMP

    MDR report key: 11629017 · Received April 6, 2021

    Report

    Report Number
    MW5100614
    Event Type
    Injury
    Date Received
    April 6, 2021
    Date of Event
    March 31, 2021
    Report Date
    March 31, 2021
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FRN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    SPONTANEOUS CALL FROM PATIENT TODAY STATING PUMP 924929 MAKING AN ABNORMAL SOUND LIKE A MOTOR BOAT. PATIENT ALSO STATED HE STARTED TO FEEL DROWSY AND APPEARED PUMP WAS INFUSING FASTER THAN IT SHOULD. HE SWITCHED TO BACK UP PUMP AND AFTER 30 MINUTES, FELT FINE. PUMP WAS INFUSE WHEN FAULT OCCURRED. NO LAPSE IN INFUSION DUE TO MALFUNCTION. SENDING REPLACEMENT PUMP AND PATIENT WILL RETURN MALFUNCTIONING PUMP. PATIENT DOES HAVE BACK UP PUMP AND SUCCESSFULLY CONTINUED THEIR INFUSION. INFUSION IS LIFE-SUSTAINING. OUTCOME - RESOLVED. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523010 CADD LEGACY PUMP PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR