BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD

    MDR report key: 13952529 · Received March 30, 2022

    Report

    Report Number
    3012307300-2022-05531
    Event Type
    Malfunction
    Date Received
    March 30, 2022
    Date of Event
    January 18, 2022
    Report Date
    August 9, 2022
    Manufacturer
    ST PAUL
    Product Code
    FPA
    UDI-DI
    10610586027239
    PMA / PMN Number
    K040636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B5: ADDITIONAL INFORMATION: MEDWATCH REPORT MW5108055 RECEIVED 20/APR/2022., CORRECTED DATA: H6: CORRECTION: EVENT PROBLEM PATIENT CODE: 4582-NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS C106106.

    Description of Event or Problem · 0

    2/2 REFERENCE (B)(6) FOR ALL ATTACHMENTS AND RELATED COMPLAINTS) PER COMPLAINT FORM: OUTBOUND. PATIENT REPORTED IN THE PAST WEEK TWO CASSETTES CAUSED BOTH PUMPS TO ALARM NO DISPOSABLE AND HAD TO BE DISCARDED AFTER THE INFUSIONS HAD STARTED. STATED ONE TIME, THE ALARM WAS AT NIGHT AND PATIENT STATED SHE DID NOT HEAR THE PUMP AND DID NOT KNOW HOW IT HAD ALARMED. STATED SHE DID FEEL BAD BUT DID NOT SEEK ADDITIONAL CARE. LOT NUMBER 4173642. CASSETTES NOT AVAILABLE FOR RETURN AS PT DISPOSED OF THEM. NO FURTHER DETAILS PROVIDED. NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2905096 CADD SET,ADMINISTRATION, INTRAVASCULAR FPA ST PAUL 21-7302-24 4173642 10610586027239

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown