BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD-LEGACY ONE AMBULATORY INFUSION PUMP

    MDR report key: 19929082 · Received August 7, 2024

    Report

    Report Number
    3012307300-2024-07274
    Event Type
    Malfunction
    Date Received
    August 7, 2024
    Date of Event
    July 1, 2024
    Report Date
    October 17, 2024
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FRN
    UDI-DI
    10610586019548
    PMA / PMN Number
    K982838
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H3, H6: INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    H3: NO DEVICE OR DEVICE PHOTO WAS RETURNED FOR INVESTIGATION. DUE TO THIS, NO ROOT CAUSE WAS DETERMINED AS A PRODUCT EVALUATION AND PROBLEM CONFIRMATION CANNOT BE PERFORMED. NO PREVIOUS REPAIR HAS BEEN NOTED IN THE LAST 12 MONTHS AND NO EVENT LOG HISTORY WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PUMP WAS ADMINISTERING TOO MUCH MEDICATION AND HAD ABOUT 8 ML LEFT. THE OTHER PUMPS USUALLY HAD ROUND 16 ML LEFT ON THE RESERVOIR VOLUME AT THE END OF INFUSION. THE DOSE AND ROUTE PRESCRIBED WAS A REMODULIN DOSE - 80 NG/KG/M IN INTRAVENOUS, CONTINUOUS FREQUENCY AND THE STARTED DATE WAS (B)(6) 2024. THE MEDICATIONS THE PATIENT WAS USING AT OR AROUND THE TIME OF THE ADVERSE EVENT WERE SPIRONOLACTONE, BUMETANIDE, LOVENOX, LIPITOR, WINREVAIR, AMBRISENTAN, REVATIO, OXYGEN, REMODULIN DILUENT AND FISH OIL. THE PRODUCT FAULT OCCURRED WHILE IN USE WITH THE PATIENT. THERE WAS A PATIENT INVOLVEMENT, AND THE PATIENT HARM/ADVERSE EVENT REPORTED WERE HEADACHE, NAUSEA, FELT SHAKY AND HAD LOW BLOOD PRESSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219513 CADD-LEGACY ONE AMBULATORY INFUSION PUMP PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC. 6400 10610586019548

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Female AMBRISENTAN| BUMETANIDE| FISH OIL| LIPITOR| LOVENOX| OXYGEN| REMODULIN DILUENT| REMODULIN DOSE 80 NG/KG/M IV, CONTINUOUS FREQUENCY| REVATIO| SPIRONOLACTONE| WINREVAIR