BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD® CADD-LEGACY® 1 PUMP

    MDR report key: 8041562 · Received November 6, 2018

    Report

    Report Number
    3012307300-2018-08096
    Event Type
    Malfunction
    Date Received
    November 6, 2018
    Date of Event
    September 14, 2018
    Report Date
    January 16, 2019
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FRN
    UDI-DI
    10610586019548
    PMA / PMN Number
    K982838
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE PUMP WAS RETURNED FOR ANALYSIS IN USED CONDITION. VISUAL INSPECTION OF THE PUMP SHOWED THAT THE PUMP WAS IN FAIR PHYSICAL CONDITION AS THE REAR HOUSING AND THE LENS HAD CRACKS. THE DEVICE EVENT LOG NOTED AN ERROR CODE WAS RECORDED. FUNCTIONAL TESTING INCLUDED USE TESTING. THE PUMP WAS POWERED ON AND DISPLAYED AN ERROR CODE ALARM MESSAGE. THE PUMP WAS OPENED AND A PIECE OF REAR HOUSING PLASTIC WAS FOUND STUCK IN THE MOTOR GEARS RESULTING IN THE MOTOR LOCKING UP. THE REAR HOUSING, FRONT HOUSING ALONG WITH THE OPTICAL SWITCH, AND THE FLAG GEAR WERE REPLACED. BASED ON THE EVIDENCE, THE COMPLAINT WAS CONFIRMED. THE ROOT CAUSE WAS ATTRIBUTED TO PUMP DAMAGE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED THAT THIS EVENT OCCURRED DURING BENCH TESTING AND THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT THIS AMBULATORY INFUSION PUMP EXHIBITED AN ERROR CODE. IT WAS NOT SPECIFIED WHETHER OR NOT THIS OCCURRED DURING INFUSION OR INTERRUPTED THERAPY. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    881986 CADD® CADD-LEGACY® 1 PUMP PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC. 6400 10610586019548

    Patients

    Seq Age Sex Outcome Treatment
    1