BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD LEGACY PLUS PUMP

    MDR report key: 12018252 · Received June 17, 2021

    Report

    Report Number
    3012307300-2021-06192
    Event Type
    Malfunction
    Date Received
    June 17, 2021
    Date of Event
    April 20, 2021
    Report Date
    March 16, 2023
    Manufacturer
    ST PAUL
    Product Code
    FRN
    UDI-DI
    10610586019647
    PMA / PMN Number
    K982836
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REMEDIATION MDR WAS GENERATED UNDER PROTOCOL (B)(4). AS A RESULT OF WARNING LETTER CMS (B)(4). NO PRODUCT SAMPLE WAS RECEIVED/ THEREFORE, VISUAL AND FUNCTIONAL TESTING COULD NOT BE PERFORMED. A DHR REVIEW COULD NOT BE PERFORMED. AND THAT NO SPECIFIC PRODUCT WAS IDENTIFIED. NO SERIAL NUMBER WAS PROVIDED. THE REPORTED ISSUE COULD NOT BE CONFIRMED, AS NO PRODUCT SAMPLE WAS RECEIVED FOR EVALUATION. IF THE PRODUCT IS RETURNED, THE MANUFACTURER WILL REOPEN THIS COMPLAINT, FOR FURTHER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    POTENTIAL LOT NUMBER: 4092493, 4046848, 4103109. ADDITIONAL CONTACT: (B)(6).

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL CADD LEGACY PLUS PUMP DISPLAYED A "NO DISPOSABLE" ALARMS WHILE INFUSING A BOLUS OF CHEMOTHERAPY AGENT (FLUOROURACIL). THE PATIENT WAS REQUIRED TO GO INTO THE CLINIC SOONER AND THERE WERE SOME INSTANCES WHERE THE DRUG INFUSED TOO QUICKLY. THE INFUSION WAS LIFE SUSTAINING AND THE PATIENT WAS UNABLE TO RECEIVE THE REMAINING INFUSION VOLUME. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    916216 CADD LEGACY PLUS PUMP PUMP, INFUSION FRN ST PAUL 6500 10610586019647

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown