BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD MEDICATION CASSETTE

    MDR report key: 14427765 · Received May 18, 2022

    Report

    Report Number
    3012307300-2022-08948
    Event Type
    Malfunction
    Date Received
    May 18, 2022
    Date of Event
    March 17, 2022
    Report Date
    May 27, 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
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THERE WAS NO PATIENT INJURY. CORRECTED DATA: UPDATED D1 AND D4: MODEL NUMBER SHOULD BE NULL.

    Description of Event or Problem · 0

    PER MEDWATCH (MW5108342 REPORT DATE:17-MAR-2022): SPONTANEOUS CALL FORM PATIENT TO REPORT PUMP ALARM 'NO DISPOSABLE' ERROR WHICH HAS HAPPENED IN THE PAST. SHE SWITCHED TO HER BACK UP PUMP AND WAS INFUSING JUST FINE. SHE DID NOT WANT PUMP REPLACED AND THINKS MORE THAN LIKELY THIS IS NOT A PUMP ISSUE BUT A CASSETTE ISSUE- SHE PROVIDED CASSETTE LOT#4220003.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1803298 CADD MEDICATION CASSETTE SET,ADMINISTRATION,INTRAVASCULAR FPA ST PAUL 21-7302-24 4220003 10610586027239

    Patients

    Seq Age Sex Outcome Treatment
    1 Female