BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD

    MDR report key: 11904602 · Received May 28, 2021

    Report

    Report Number
    3012307300-2021-05062
    Event Type
    Malfunction
    Date Received
    May 28, 2021
    Date of Event
    April 23, 2021
    Report Date
    May 28, 2021
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER DID NOT PROVIDE THE SERIAL NUMBER OR THE PART NUMBER OF THE AFFECTED DEVICE.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED REGARDING A CADD LEGACY PUMP. IT WAS REPORTED THAT THE DEVICE JUST STOPPED WORKING. IT HAPPED TO BE THE PATIENT'S BACK UP PUMP, SO THERE WAS NO OTHER PUMP TO USE. PATIENT HAD TO BE TRANSFERRED TO THE HOSPITAL VIA AMBULANCE FROM CONTINUED INFUSION. PATIENT WAS OFF VELETRI FOR ABOUT 30 MINUTES AT THE TIME OF THE CALL. THEY WERE ON 48 NKM OF THEIR CONTINUOUS IV INFUSION. SEVERITY OF SIDE EFFECTS OR INJURY FROM THE MALFUNCTION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    801827 CADD INFUSION PUMP FRN

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR