BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CADD

    MDR report key: 11800954 · Received May 10, 2021

    Report

    Report Number
    3012307300-2021-04159
    Event Type
    Injury
    Date Received
    May 10, 2021
    Date of Event
    April 7, 2021
    Report Date
    May 10, 2021
    Manufacturer
    ST PAUL
    Product Code
    FRN
    UDI-DI
    10610586029554
    PMA / PMN Number
    K051568
    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 AMBULATORY INFUSION PUMPS/CADD MS3 PUMPS UNDER INFUSED AS THE PATIENT HER CASSETTE WAS STILL FULL AFTER 24 HOURS OF INFUSION. PATIENT RECEIVES: REMODULIN MDV 5MG/ML, DOSE OR AMOUNT: 45.62 NG/KG/MIN FOR PULMONARY ARTERIAL HYPERTENSION. SHE HAD NOTIFIED DOCTOR AND NURSE, SHE WAS INSTRUCTED BY THEM THAT SHE SHOULD GO TO HOSPITAL IF SHE SHOULD BECOME SYMPTOMATIC AND CONDITION WORSENS. PATIENT HAD A BACK UP PUMP SHE SUCCESSFULLY SWITCHED TO. HOWEVER, PATIENT REPORTED TO BE SYMPTOMATIC FEELING CLAMMY AND LOUSY. TIME LAPSE OF UNDER INFUSION MAY HAVE CONTRIBUTED TO EVENT. MEDICATION IS LIFE SUSTAINING. THE EVENT WAS ISOLATED TO A PUMP ISSUE AND NOT CASSETTE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    697768 CADD MS3 SLATE FRN ST PAUL 7400 10610586029554

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR