BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD LEGACY G400

    MDR report key: 8199764 · Received December 26, 2018

    Report

    Report Number
    MW5082631
    Event Type
    Malfunction
    Date Received
    December 26, 2018
    Date of Event
    December 10, 2018
    Report Date
    December 10, 2018
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    SPONTANEOUS CALL FROM PATIENT WHO STATES SN# (B)(4) IS ALARMING WITH ERROR MESSAGE "ERROR 1320" AND UNABLE TO TROUBLESHOOT. ADVISED PUMP NEEDS TO BE BROUGHT IN TO ASSESS. PATIENT HAS A BACKUP PUMP TO SWITCH TO. IS THE ACTUAL DEVICE AVAILABLE TO BE RETURNED FOR INVESTIGATION? YES. DID WE REPLACE THE DEVICE? YES. WHAT IS THE SERIAL NUMBER OF THE MALFUNCTION PUMP? (B)(4). DID THE REPORTED PRODUCT FAULT OCCUR WHILE IN USE WITH A PATIENT? NO. DID THE PRODUCT ISSUE CAUSE OR CONTRIBUTE TO PATIENT OR CLINICAL INJURY? NO. REPORTED TO (B)(6) BY: PATIENT/CAREGIVER. STRENGTH 2.5 MG/ML. DOSE OR AMOUNT: 40NG/KG/MIN. FREQUENCY: CONTINUOUS. ROUTE: IV. DATES OF USE: FROM (B)(6) 2018 TO ONGOING. DIAGNOSIS OR REASON FOR USE: PAH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1037503 CADD LEGACY G400 PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR