BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD-SOLIS AMBULATORY INFUSION PUMP

    MDR report key: 19559758 · Received June 18, 2024

    Report

    Report Number
    3012307300-2024-05139
    Event Type
    Malfunction
    Date Received
    June 18, 2024
    Date of Event
    May 3, 2024
    Report Date
    June 18, 2024
    Manufacturer
    SMITHS MEDICAL ASD, INC
    Product Code
    MEA
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ONE DEVICE WAS RECEIVED. A VISUAL INSPECTION NOTED THAT THE TAMPER SEAL WAS MISSING, BUT THE DEVICE WAS IN GOOD CONDITION, NO PHYSICAL DAMAGE WAS FOUND ON THE PUMP. FUNCTIONAL TESTING WAS CONDUCTED. THE LAST ERROR CODE (LEC) 46442 WAS DISPLAYED IN THE DEVICE INFORMATION AND THEREFORE THE CUSTOMERS PROBLEM WAS REPLICATED DURING FUNCTIONAL TESTING. NO ROOT CAUSE COULD BE ESTABLISHED. SERVICE HISTORY REVIEW IDENTIFIED THIS DEVICE HAS NOT BEEN IN BEFORE FOR REPAIR RELATED TO THE CUSTOMER STATED PROBLEM. AS A RESULT, LEC 46442 WILL BE DELETED, AND A LONG-TERM TEST EXECUTED.

    Additional Manufacturer Narrative · 0

    ONE DEVICE WAS RECEIVED. A VISUAL INSPECTION NOTED THAT THE TAMPER SEAL WAS MISSING, BUT THE DEVICE WAS IN GOOD CONDITION, NO PHYSICAL DAMAGE WAS FOUND ON THE PUMP. FUNCTIONAL TESTING WAS CONDUCTED. THE LAST ERROR CODE (LEC) 46442 WAS DISPLAYED IN THE DEVICE INFORMATION AND THEREFORE THE CUSTOMERS PROBLEM WAS REPLICATED DURING FUNCTIONAL TESTING. NO ROOT CAUSE COULD BE ESTABLISHED. SERVICE HISTORY REVIEW IDENTIFIED THIS DEVICE HAS NOT BEEN IN BEFORE FOR REPAIR RELATED TO THE CUSTOMER STATED PROBLEM. AS A RESULT, LEC 46442 WILL BE DELETED, AND A LONG-TERM TEST EXECUTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE EXHIBITED AN "ERROR CODE 46442". THERE WAS UNKNOWN PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE EXHIBITED AN "ERROR CODE 46442". THERE WAS UNKNOWN PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1072157 CADD-SOLIS AMBULATORY INFUSION PUMP PUMP, INFUSION, PCA MEA SMITHS MEDICAL ASD, INC 2110

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown