BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3012307300-2020-07747

    MDR report key: 10359178 · Received August 3, 2020

    Report

    Report Number
    3012307300-2020-07747
    Event Type
    Injury
    Date Received
    August 3, 2020
    Date of Event
    June 29, 2020
    Report Date
    August 3, 2020
    Manufacturer
    ST PAUL
    Product Code
    FRN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    INFORMATION RECEIVED A SMITHS MEDICAL PUMP PER MEDWATCH: CALLED PATIENT TO COMPLETE HIS ORDER FOR REMODULIN AND TITRATION AND PER HIS BROTHER, HE IS CURRENTLY IN THE HOSPITAL AND HAS BEEN FOR TWO DAYS. HIS REMODULIN PUMP SHUT OFF, THEY DON'T KNOW FOR HOW LONG OR WHY AND HE ENDED UP HAVING A SEIZURE. A MALE (B)(6) YEARS OF AGE IS ON REMODULIN MDV, STRENGTH: 5MB\ML. FOR PULMONARY ARTERIAL HYPERTENSION. ALSO PRESCRIBED LEAP. NO PUMP WAS RETURNED AND UNKNOWN SERIAL NUMBER, AS PATIENT RESIDES STILL IN HOSPITAL. SEIZURES CAN BE A RESULT OF HYPOXIA WHICH MAY HAVE BEEN CONTRIBUTED BY PUMP MALFUNCTION. THE DIAGNOSES OF ARTERIAL PULMONARY HYPERTENSION WOULD HAVE EXPERIENCED ALTERED RESPIRATORY STATUS. THIS WOULD CAUSE OCCLUSION TO ARTERIAL ARTERIES PREVENTING LUNG EXPANSION AND OXYGEN EXCHANGE IN THE AVEOLI LUNG TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    824334 FRN ST PAUL

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Hospitalization