BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CADD - SOLIS AMBULATORY INFUSION PUMP

    MDR report key: 3082923 · Received April 22, 2013

    Report

    Report Number
    2183502-2013-00170
    Event Type
    Injury
    Date Received
    April 22, 2013
    Report Date
    April 19, 2013
    Manufacturer
    SMITHS MEDICAL MD
    Product Code
    MEA
    PMA / PMN Number
    K040899
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    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

    ACCORDING TO USER FACILITY THE PUMP WAS IN USE TO ADMINISTER PCA MEDICATION TO A PT. THE REPORTER STATED THAT THE PUMP CAUSED THE PT TO GO INTO RESPIRATORY ARREST. NO INFORMATION WAS PROVIDED TO INDICATE PUMP OPERATION ISSUES CAUSED THE PT INJURY. USER FACILITY ONLY REPORTED ISSUES DOWNLOADING THE PUMP HISTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173020 CADD - SOLIS AMBULATORY INFUSION PUMP MEA - PUMP, INFUSION, PCA MEA SMITHS MEDICAL MD 2100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NONE Life Threatening