BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD® CADD®-SOLIS VIP AMBULATORY INFUSION PUMP

    MDR report key: 7980352 · Received October 18, 2018

    Report

    Report Number
    3012307300-2018-04198
    Event Type
    Malfunction
    Date Received
    October 18, 2018
    Report Date
    October 18, 2018
    Manufacturer
    SMITHS MEDICAL, ASD, INC.
    Product Code
    FRN
    UDI-DI
    10610586042829
    PMA / PMN Number
    K111275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE CADD®-SOLIS AMBULATORY INFUSION PUMP WAS RETURNED FOR ANALYSIS. THE CUSTOMER'S REPORTED PROBLEM WAS "CASSETTE ISSUE". THE PUMP WAS FOUND TO BE IN GOOD PHYSICAL CONDITION. THE EVENT LOG REVEALED ERROR HIGH ALARM DISPLAYED: CASSETTE NOT ATTACHED PROPERLY. THE CUSTOMER'S REPORTED PROBLEM WAS VERIFIED. THE DEVICE WAS POWERED ON AND A CASSETTE WAS ATTACHED. THE PUMP ALARMED THAT THE CASSETTE WAS NOT ATTACHED PROPERLY. THE DEVICE WAS POWERED OFF THEN POWERED ON IN MANUFACTURING UTILITY MODE. THIS WAS TO VERIFY DOWNSTREAM SENSOR CALIBRATION AND TO ATTEMPT RECALIBRATION OF THE SENSOR. THE SENSOR WOULD NOT ALLOW CALIBRATION DUE TO A MALFUNCTION WITH THE SENSOR. WHAT CAUSED THE REPORTED PROBLEM WAS DETERMINED TO BE A FAULTY DOWNSTREAM SENSOR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CADD® CADD®-SOLIS VIP AMBULATORY INFUSION PUMP HAD A CASSETTE ISSUE. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    821637 CADD® CADD®-SOLIS VIP AMBULATORY INFUSION PUMP PUMP, INFUSION FRN SMITHS MEDICAL, ASD, INC. 10610586042829

    Patients

    Seq Age Sex Outcome Treatment
    1