BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD

    MDR report key: 14591503 · Received June 3, 2022

    Report

    Report Number
    3012307300-2022-10593
    Event Type
    Malfunction
    Date Received
    June 3, 2022
    Report Date
    June 3, 2022
    Manufacturer
    ST PAUL
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    (2/2 REFERENCE (B)(4) FOR RELATED COMPLAINTS) (DOCUMENTING CASSETTE) IT WAS REPORTED THAT THE RESERVOIR VOLUME NUMBER HAD NOT CHANGED FOR PAST 2 HOURS FOR THE PUMP. STATED HER FACE WAS COLD, HAD LEFT SIDED CHEST PAIN, AND FELT EXTREMELY WEAK AND TIRED. STATED WHEN HOME, SWITCHED TO NEW CASSETTE AND PUMP AND REMODULIN INFUSING PAST 15 MINUTES, RESERVOIR VOLUME NUMBER HAD. DECREASED TO 97.8 MILLILITERS. AND RATE 36 MILLILITERS PER DAY. STATED FACE WAS FEELING WARMER BUT STILL HAD CHEST PAIN DISCOMFORT. STATED SHE HAD BEEN IN THE EMERGENCY ROOM THIS WEEK. FOR SAME CHEST PAIN BUT HAD PALPITATIONS AND WATER RETENTION IN THE STOMACH AREA. STATED NO PALPITATIONS NOW. PUMP SERIAL NUMBER (B)(4). PUMP REPLACED. NO FURTHER DETAILS PROVIDED. DRUG DETAILS: DRUG NAME, STRENGTH AND FORMULATION: REMODULIN 10MG/ML. MANUFACTURER: UNITED THERAPEUTICS DOSE AND ROUTE PRESCRIBED: REMODULIN - 120 NG/KG/MIN - INTRAVENOUS. FREQUENCY: CONTINUOUS. START DATE: (B)(6) 2020. LOT # 2101981 - EXPIRATION DATE 11/30/2022. INDICATION/DIAGNOSIS FOR USE: PRIMARY PULMONARY ARTERIAL HYPERTENSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1556841 CADD SET,ADMINISTRATION,INTRAVASCULAR FPA ST PAUL

    Patients

    Seq Age Sex Outcome Treatment
    1 Female