BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD-MS3 AMBULATORY INFUSION PUMP

    MDR report key: 7957193 · Received October 11, 2018

    Report

    Report Number
    3012307300-2018-00041
    Event Type
    Malfunction
    Date Received
    October 11, 2018
    Report Date
    December 4, 2018
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FRN
    UDI-DI
    10610586029554
    PMA / PMN Number
    K051568
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ONE PUMP WAS RETURNED FOR ANALYSIS IN USED CONDITION. FUNCTIONAL TESTING INCLUDED USE TESTING. THE PUMP DISPLAYED AN ERROR CODE. IT WAS FOUND THAT THE PUMP'S DOWNSTREAM OCCLUSION SENSOR WAS SHATTERED. THIS EXPLAINS WHY THE PUMP WOULD NOT DETECT THE CARTRIDGE. THE DOWNSTREAM OCCLUSION SENSOR WAS REPLACED. BASED ON THE EVIDENCE, THE COMPLAINT WAS CONFIRMED. THE ROOT CAUSE WAS ATTRIBUTED TO THE PUMP'S DOWNSTREAM OCCLUSION SENSOR.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT THE CADD MS3 PUMP WON'T DETECT CARTRIDGE. NO REPORTED ADVERSE EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    798392 CADD-MS3 AMBULATORY INFUSION PUMP PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC. 7400 10610586029554

    Patients

    Seq Age Sex Outcome Treatment
    1