BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD LEGACY PLUS PUMP

    MDR report key: 12303106 · Received August 10, 2021

    Report

    Report Number
    3012307300-2021-08278
    Event Type
    Malfunction
    Date Received
    August 10, 2021
    Date of Event
    July 8, 2021
    Report Date
    March 3, 2022
    Manufacturer
    ST PAUL
    Product Code
    FRN
    UDI-DI
    10610586019647
    PMA / PMN Number
    K982836
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: CUSTOMER REPORTED THAT THE CARTRIDGE PUMP WON'T RUN ERROR MESSAGE. TAMPER SEALS WERE ALL INTACT. PERFORMED THREE SEPARATE DELIVERY ACCURACY TESTS AND NDA TESTING. UNABLE TO DETERMINE WHO OR WHAT CAUSED THE PROBLEM. REPLACED DOWNSTREAM SENSOR.

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: CUSTOMER REPORTED THAT THE CARTRIDGE PUMP WON'T RUN ERROR MESSAGE. TAMPER SEALS WERE ALL INTACT. PERFORMED THREE SEPARATE DELIVERY ACCURACY TESTS AND NDA TESTING. UNABLE TO DETERMINE WHO OR WHAT CAUSED THE PROBLEM. REPLACED DOWNSTREAM SENSOR.

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: CUSTOMER REPORTED THAT THE CARTRIDGE PUMP WON'T RUN ERROR MESSAGE. TAMPER SEALS WERE ALL INTACT. PERFORMED THREE SEPARATE DELIVERY ACCURACY TESTS AND NDA TESTING. UNABLE TO DETERMINE WHO OR WHAT CAUSED THE PROBLEM. REPLACED DOWNSTREAM SENSOR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CARTRIDGE PUMP WON'T RUN ERROR MESSAGE, NOT GIVING MEDICATION PROPERLY AND SENSOR IS BAD INTERNALLY. NO PATIENT INJURY WAS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CARTRIDGE PUMP WON'T RUN ERROR MESSAGE, NOT GIVING MEDICATION PROPERLY AND SENSOR IS BAD INTERNALLY. NO PATIENT INJURY WAS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CARTRIDGE PUMP WON'T RUN ERROR MESSAGE, NOT GIVING MEDICATION PROPERLY AND SENSOR IS BAD INTERNALLY. NO PATIENT INJURY WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SMITHS MEDICAL PUMP EXHIBITED A FAULTY SENSOR WHICH CAUSED IT TO ALARM "NO DISPOSABLE, PUMP WON'T RUN" RESULTING IN 1.8 ML UNDER-INFUSED AND REMAINING IN THE CARTRIDGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1197330 CADD LEGACY PLUS PUMP PUMP, INFUSION FRN ST PAUL 21-6500-51 10610586019647

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown