BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CADD MS3 PUMPS

    MDR report key: 14015945 · Received April 5, 2022

    Report

    Report Number
    3012307300-2022-05862
    Event Type
    Injury
    Date Received
    April 5, 2022
    Report Date
    April 3, 2023
    Manufacturer
    ST PAUL
    Product Code
    FRN
    UDI-DI
    10610586029554
    PMA / PMN Number
    K051568
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MDR WAS GENERATED UNDER PROTOCOL (B)(4), AS A RESULT OF WARNING LETTER CMS# (B)(4). NO PRODUCT SAMPLE WAS RECEIVED; THEREFORE, VISUAL AND FUNCTIONAL TESTING COULD NOT BE PERFORMED. THE REPORTED ISSUE COULD NOT BE CONFIRMED AS NO PRODUCT SAMPLE WAS RECEIVED FOR EVALUATION. IF THE PRODUCT IS RETURNED, THE MANUFACTURER WILL REOPEN THIS COMPLAINT FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 0

    (2/2, REFERENCE (B)(6) FOR RELATED COMPLAINTS) (DOCUMENTING PUMP (B)(4)) IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED FROM ON (B)(6) 2022 DUE TO CADD MS3 PUMP STOPPED WORKING AND WAS NOT GETTING ANY MEDICATION. PUMP WAS REPROGRAMMED SUCCESSFULLY. (B)(4). NO FURTHER DETAILS PROVIDED. REMODULIN STRENGTH: 10 MG/ML. DOSE: 40 NG/KG/MIN. SUBCUT. FREQUENCY: CONTINUOUS. DATE OF USE: START DATE (B)(6) 2021. LOT NUMBER 2101926, EXPIRATION 11/30/2022. INDICATION/DIAGNOSIS: PRIMARY PULMONARY ARTERIAL HYPERTENSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1696520 CADD MS3 PUMPS PUMP, INFUSION FRN ST PAUL 21-7411-51 10610586029554

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization