BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD-MS 3 AMBULATORY INFUSION PUMP

    MDR report key: 13548019 · Received February 17, 2022

    Report

    Report Number
    3012307300-2022-03524
    Event Type
    Malfunction
    Date Received
    February 17, 2022
    Report Date
    February 17, 2022
    Manufacturer
    ST PAUL
    Product Code
    FRN
    UDI-DI
    10610586029554
    PMA / PMN Number
    K051568
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL CONTACT INFORMATION: (B)(6).

    Additional Manufacturer Narrative · 0

    ADDITIONAL CONTACT INFORMATION: (B)(6).

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED INDICATING THAT A CADD MS3, PUMP WAS NOT RUNNING FOR THREE DAYS BUT PUMP WAS SHOWING IT WAS RUNNING. IT WAS REPORTED THE END USER WAS FEELING LIGHTHEADED, WEAK AND TIRED AND WAS ADVISED BY HER DOCTOR TO DECREASE THE RATE FROM 0.038ML.HR TO 0.028ML.HR AND CONTACT THE DOCTOR AGAIN IN AN HOUR. PER REPORTER A BACKUP PUMP WAS USED TO RESTART THE REMODULIN AT 0.038ML.HR, AFTER ABOUT 15 MINUTES THE END USER WAS REPORTED TO BE "FEELING A LITTLE FUNNY". IT WAS REPORTED THE PUMP WAS REPLACED. MEDICATION: REMODULIN 10MG/ML, UNITED THERAPEUTICS. DOSE: 78 NG/KG/MIN: SUBCUT. FREQUENCY: CONTINUOUS. START DATE: (B)(6) 2021. LOT#: 2101723. EXPIRATION DATE: (B)(6) 2022. DIAGNOSIS: PULMONARY ARTERIAL HYPERTENSION (PAH).

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED INDICATING THAT A CADD MS3, PUMP WAS NOT RUNNING FOR THREE DAYS BUT PUMP WAS SHOWING IT WAS RUNNING. IT WAS REPORTED THE END USER WAS FEELING LIGHTHEADED, WEAK AND TIRED AND WAS ADVISED BY HER DOCTOR TO DECREASE THE RATE FROM 0.038ML.HR TO 0.028ML.HR AND CONTACT THE DOCTOR AGAIN IN AN HOUR. PER REPORTER A BACKUP PUMP WAS USED TO RESTART THE REMODULIN AT 0.038ML.HR, AFTER ABOUT 15 MINUTES THE END USER WAS REPORTED TO BE "FEELING A LITTLE FUNNY". IT WAS REPORTED THE PUMP WAS REPLACED. MEDICATION: REMODULIN 10MG/ML, UNITED THERAPEUTICS. DOSE: 78 NG/KG/MIN: SUBCUT. FREQUENCY: CONTINUOUS. START DATE: (B)(6) 2021. LOT#: 2101723. EXPIRATION DATE: 04/30/2022. DIAGNOSIS: PULMONARY ARTERIAL HYPERTENSION (PAH).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1862181 CADD-MS 3 AMBULATORY INFUSION PUMP PUMP, INFUSION FRN ST PAUL 7400 10610586029554

    Patients

    Seq Age Sex Outcome Treatment
    1 Female