BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CADD-PRIZM VIP AMBULATORY INFUSION PUMP

    MDR report key: 3900967 · Received June 11, 2014

    Report

    Report Number
    2183502-2014-00394
    Event Type
    Injury
    Date Received
    June 11, 2014
    Date of Event
    May 11, 2014
    Report Date
    June 10, 2014
    Manufacturer
    SMITHS MEDICAL
    Product Code
    FRN
    PMA / PMN Number
    K960826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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

    USER FACILITY REPORTED THAT THE DEVICE WAS IN USE WITH HOME CARE PATIENT FOR INFUSION OF SALINE. ACCORDING TO REPORTER THE INFUSION HAD BEEN IN PROGRESS FOR 15 MINUTES WHEN THE PATIENT WAS FOUND BY A NURSE TO BE INCOHERENT AND IN PAIN. THE NURSE NOTED THAT THE PATIENT'S INFUSION SET HAD AIR IN-LINE, BUT THERE WAS NO ALARM. THE PATIENT WAS IMMEDIATELY BROUGHT TO A HOSPITAL AND EVALUATED FOR AIR EMBOLISM. NO AIR EMBOLISM WAS DETECTED. PATIENT IS CURRENTLY BEING MONITORED. NO PERMANENT ADVERSE EFFECTS TO PATIENT HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346130 CADD-PRIZM VIP AMBULATORY INFUSION PUMP AMBULATORY INFUSION PUMP FRN SMITHS MEDICAL 21-8821 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization