BEUDAMED
    FDA Adverse Event Death Summary report: N

    CADD

    MDR report key: 12930372 · Received December 4, 2021

    Report

    Report Number
    3012307300-2021-12236
    Event Type
    Death
    Date Received
    December 4, 2021
    Date of Event
    November 11, 2021
    Report Date
    April 28, 2022
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FRN
    UDI-DI
    15019517126587
    PMA / PMN Number
    K111275
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER TEXT: ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE PUMP WAS PRIMED BEFORE USE, THE INFUSION RAN FOR 24 HOURS, IT WAS ALSO INFORMED THAT THE UPSTREAM OCCLUSION SENSOR WAS ON, AND THAT THE DOWNSTREAM SENSITIVITY WAS SET ON HIGH. IN ADDITION WE WERE INFORMED THAT THE PATIENT DID NOT EXPIRE AT THE TIME THE EVENT OCCURRED. THE PUMP FAILURE RESULTED IN A HOSPITALIZATION. NELC DOES NOT HAVE ACCESS TO THESE RECORDS AS THE PATIENT WAS ADMITTED TO A NON-MEMBER HOSPITAL AND REQUESTED TO BE DISCHARGED FROM SERVICES DUE TO THE ERROR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SMITHS MEDICAL PUMP DID NOT DELIVER MEDICATION. THE PATIENT'S CAREGIVER REPORTS SHE WENT TO CHANGE THE MILRINONE BAG AND IT WAS COMPLETELY FULL ALTHOUGH THE CADD SOLIS SCREEN READ TIME REMAINING 40 MINUTES. PCG HANDED PHONE OVER TO HER SISTER AND WE CONFIRMED THAT THEY HAD HOOKED THE PATIENT UP WITH THE BACK UP PUMP SERIAL # (B)(4), CONFIRMED SETTINGS WITH A RES VOL OF 183.5MLS AND CONTINUOUS RATE OF 7.5MLS. WE THEN REVIEWED THE NEWER PUMP SERIAL # (B)(4) THAT WAS DELIVERED RECENTLY DUE TO THE OLDER PUMPS LATCH BEING LOOSE. THIS PUMPS RES VOL WAS 2.9MLS WITH A CONTINUOUS RATE OF 7.5MLS. BUT THEY REPORT THIS BAG WAS COMPLETELY FULL. THEY DENY HEARING ANY ALARMS. REVIEW OF THE EVENT LOG DID NOT REVEAL ANY ALARMS. WE THEN REVIEWED THE NEWER PUMP SERIAL # (B)(4) THAT WAS DELIVERED RECENTLY DUE TO THE OLDER PUMPS LATCH BEING LOOSE. THIS PUMPS RES VOL WAS 2.9MLS WITH A CONTINUOUS RATE OF 7.5MLS. BUT THEY REPORT THIS BAG WAS COMPLETELY FULL. THEY DENY HEARING ANY ALARMS. REVIEW OF THE EVENT LOG DID NOT REVEAL ANY ALARMS. THE CAREGIVERS DECIDED TO CALL THE AMBULANCE WHICH HAD ARRIVED AT THE END OF THE CALL. ON (B)(6) 2021, SMITHS MEDICAL LEANED VIA A VERBAL STATEMENT FROM THE ACCOUNT EXECUTIVE: THE PATIENT EXPIRED IN THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1828212 CADD PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC. 2120 4152748 15019517126587

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Death