BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD LEGACY PUPMP

    MDR report key: 19999301 · Received August 18, 2024

    Report

    Report Number
    3012307300-2024-07780
    Event Type
    Malfunction
    Date Received
    August 18, 2024
    Date of Event
    July 1, 2024
    Report Date
    September 23, 2024
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FRN
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    B3: UNKNOWN; NO INFORMATION HAS BEEN PROVIDED TO DATE. 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

    DEVICE WAS NOT RETURNED FOR ROOT CAUSE ANALYSIS. NO PHOTOGRAPHIC EVIDENCE WAS PROVIDED TO AID IN INVESTIGATION. SERIAL NUMBER WAS NOT PROVIDED TO REVIEW PREVIOUS REPAIRS. BASED ON THE REVIEW OF INFORMATION PROVIDED FROM THE CUSTOMER WE ARE UNABLE TO DETERMINE A PROBABLE CAUSE AS THE DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A HIGH-PRESSURE ALARM ON BOTH PUMPS. PER REPORTER, THE CASSETTE WAS CHANGED TO THE BACKUP PUMP, BUT THE ISSUE WAS NOT RESOLVED. PER THE REPORTER, THE BATTERIES WERE ALSO REMOVED TO STOP THE ALARM. PER THE REPORTER THE PATIENT WAS MAKING NEW CASSETTE, AND THE PUMP RAN WHILE NOT CONNECTED TO THE CENTRAL LINE. PER THE REPORTER, THE EMT PRESENT HAD ADVISED TO PLACE IV SO THAT THE REMODULIN 2.5 MG/ML WOULD CONTINUE. THE DOSE AND ROUTE PRESCRIBED WAS A REMODULIN DOSE 60 NG/KG/M/N INTRAVENOUS, CONTINUOUS FREQUENCY. THERE WAS A CENTRAL LINE ISSUE. THE PATIENT WAS TRANSPORTED TO THEIR PRIMARY PHYSICIAN'S HOSPITAL. PER REPORTER, THERE WAS PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    992553 CADD LEGACY PUPMP PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female REMODULIN 2.5MG/ML.