BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3012307300-2022-02917

    MDR report key: 13482603 · Received February 8, 2022

    Report

    Report Number
    3012307300-2022-02917
    Event Type
    Malfunction
    Date Received
    February 8, 2022
    Report Date
    February 8, 2022
    Manufacturer
    NULL
    Product Code
    LHI
    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) PER ACCREDO COMPLAINT FORM: HUSBAND REPORTS PATIENT IS ANXIOUS DUE TO CADD LEGACY PUMP NO DISPOSABLE CLAMP TUBING ALARM. NEVER KNOWS WHEN IT WILL GO OFF AND DOESN'T WANT TO GO TO BED INCASE IT GOES. OFF. PATIENT WANTS OFF THE CADD PUMP. CADD LEGACY PUMP SERIAL NUMBERS (B)(4), CASSETTE LOT NUMBER NOT PROVIDED. DRUG NAME AND STRENGTH: REMODULIN 2.5MG/ML. DOSE AND ROUTE PRESCRIBED: REMODULIN,DOSE - 22 NG/KG/MIN INTRAVENOUS. FREQUENCY: CONTINUOUS. START DATE: (B)(6) 2018. LOT#: 2101979, EXPIRATION DATE : 05/31/2022. NOTE: LOT#: 2101979 FOUND INVALID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    792347 LHI

    Patients

    Seq Age Sex Outcome Treatment
    1 Female