BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD-LEGACY PLUS PUMP

    MDR report key: 15076227 · Received July 21, 2022

    Report

    Report Number
    3012307300-2022-13867
    Event Type
    Malfunction
    Date Received
    July 21, 2022
    Date of Event
    May 5, 2022
    Report Date
    July 21, 2022
    Manufacturer
    ST PAUL
    Product Code
    FRN
    UDI-DI
    10610586019647
    PMA / PMN Number
    K982836
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO INFORMATION HAS BEEN PROVIDED TO DATE. A DHR REVIEW WAS NOT CONDUCTED, BASED UPON REVIEW OF THE INFORMATION PROVIDED BY THE CUSTOMER, AS IT DOES NOT INDICATE A PROBLEM WITH THE INITIAL MANUFACTURE OR PRIOR REPAIR OF THE DEVICE. NO PRODUCT OR PHOTOGRAPHIC EVIDENCE WERE PROVIDED TO AID IN THIS INVESTIGATION. THE COMPLAINT REPORT OFFERED INSUFFICIENT DETAILS TO DETERMINE WHETHER THIS PRODUCT FUNCTIONED AS INTENDED OR WAS USED IN A MANNER CONSISTENT WITH ITS INSTRUCTIONS FOR USE (IFU) OR FAILED TO MEET PRODUCT SPECIFICATIONS. LACKING ANY ADDITIONAL EVIDENCE, THIS COMPLAINT HAS BEEN CLOSED AS UNCONFIRMED. IF THE PRODUCT IS RETURNED, THE MANUFACTURER WILL REOPEN THIS COMPLAINT FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED PER CUSTOMER FORM: THAT 5-FU PUMP WAS ORDERED ON( B)(6) 2022, 8640MG (172.8ML), QSD WITH 77.2ML NS TO A TOTAL VOLUME OF 250ML. PUMP NUMBER: 418697 WAS SET AT A RATE OF 2.6ML/HOUR FOR 96 HOURS. PATIENT WAS SEEN IN OFFICE ON (B)(6) 2022 FOR PUMP DC. IT WAS NOTED THAT THE PUMP SHOWED THAT 248.2ML WAS GIVEN BUT RESERVOIR BAG STILL LOOKED HALF FULL. THE PUMP AND BAG WERE SENT BACK TO FACILITY TO WITHDRAW THE REMAINDER FROM THE BAG. THERE WAS 141ML LEFT IN THE BAG (4873MG), SO ONLY A TOTAL OF 109ML (3767MG) WAS ACTUALLY GIVEN. THIS INFORMATION HAS BEEN GIVEN TO THE PROVIDER. PATIENT WAS RECEIVING FLUOROURACIL AND NS. PUMP HAS BEEN SET ASIDE TO RETURN AS DEFECTIVE. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262046 CADD-LEGACY PLUS PUMP PUMP, INFUSION FRN ST PAUL 21-6500-51 10610586019647

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown