BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD® CADD-LEGACY® 1 PUMP

    MDR report key: 7970658 · Received October 16, 2018

    Report

    Report Number
    3012307300-2018-04197
    Event Type
    Malfunction
    Date Received
    October 16, 2018
    Report Date
    October 16, 2018
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FRN
    UDI-DI
    10610586019548
    PMA / PMN Number
    K982838
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, 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 GOOD PHYSICAL CONDITION OTHER THAN A SCRATCHED SCREEN. THE PUMP EVENT LOG HAD NO RELATED FINDINGS. FUNCTIONAL TESTING INCLUDED USE TESTING. THE PUMP WAS STARTED IN APPLICATION AND IMMEDIATELY STARTED DOUBLE BEEPING. 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 INDICATING THAT THIS AMBULATORY INFUSION PUMP EXHIBITED A DOUBLE BEEP ALARM. 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
    809881 CADD® CADD-LEGACY® 1 PUMP PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC. 6400 10610586019548

    Patients

    Seq Age Sex Outcome Treatment
    1