BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CADD-LEGACY® PCA AMBULATORY INFUSION PUMP

    MDR report key: 5531739 · Received March 29, 2016

    Report

    Report Number
    2183502-2016-00618
    Event Type
    Injury
    Date Received
    March 29, 2016
    Report Date
    March 29, 2016
    Manufacturer
    SMITHS MEDICAL ASD INC.,
    Product Code
    MEA
    PMA / PMN Number
    K982839
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED FROM K982839 TO EXEMPT, AS DEVICE WAS APPROVED AS PART OF NDA (B)(4). (B)(4).

    Additional Manufacturer Narrative · 1

    CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MANUFACTURER FOR DEVICE EVALUATION. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION.

    Description of Event or Problem · 1

    THE DISTRIBUTOR REPORTED THAT THE LISTED PUMP WAS IN USE WITH A PATIENT WHEN ITS AUTOFUNCTION WAS FOUND NOT WORKING. THE REPORTER EXPLAINED THAT DUE TO THE PUMP NOT FUNCTIONING, THE PATIENT HAD TO BE HOSPITALIZED FOR 4 DAYS. THE REPORTER ALSO EXPLAINED THAT THE PATIENT HAS GASTROINTESTINAL ISSUES, AND THE STOMACH WAS NOT EMPTYING FOOD, BUT THE REPORTER WAS UNCLEAR IF THIS ISSUE WAS RELATED TO THE AUTOFUNCTION NOT OPERATING ON THE PUMP. ADDITIONAL INFORMATION REGARDING THE EVENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187694 CADD-LEGACY® PCA AMBULATORY INFUSION PUMP INFUSION PUMP MEA SMITHS MEDICAL ASD INC., 1400 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization