BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD LEGACY PLUS PUMP

    MDR report key: 12351760 · Received August 20, 2021

    Report

    Report Number
    3012307300-2021-08715
    Event Type
    Malfunction
    Date Received
    August 20, 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
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: CUSTOMER REPORTED THAT THERE WAS NO DISPOSABLE CLAMP ATTACHED. TAMPER SEALS WERE ALL INTACT, DEVICE WAS IN GOOD CONDITION. UNABLE TO DUPLICATE CUSTOMER'S REPORTED PROBLEM IN THE PUMP. PERFORMED VISUAL INSPECTION OF THE PUMP AND NDA TESTING. UNABLE TO DETERMINE WHAT CAUSED THE PROBLEM. REPLACED DOWNSTREAM SENSOR AS A PREVENTIVE MEASURE.

    Additional Manufacturer Narrative · 0

    CUSTOMER REPORTED THAT THE DEVICE SHOWED NO DISPOSABLE CLAMP ATTACHED. TAMPER SEALS WERE ALL INTACT, DEVICE WAS IN GOOD CONDITION. PERFORMED VISUAL INSPECTION OF THE PUMP AND NDA TESTING. UNABLE TO DETERMINE WHAT CAUSED THE PROBLEM. REPLACED DOWNSTREAM SENSOR AS A PREVENTIVE MEASURE.

    Additional Manufacturer Narrative · 0

    OTHER TEXT: CUSTOMER REPORTED THAT THERE WAS NO DISPOSABLE CLAMP ATTACHED. TAMPER SEALS WERE ALL INTACT, DEVICE WAS IN GOOD CONDITION. UNABLE TO DUPLICATE CUSTOMER'S REPORTED PROBLEM IN THE PUMP. PERFORMED VISUAL INSPECTION OF THE PUMP AND NDA TESTING. UNABLE TO DETERMINE WHAT CAUSED THE PROBLEM. REPLACED DOWNSTREAM SENSOR AS A PREVENTIVE MEASURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE HAD NO DISPOSABLE CLAMP ATTACHED. NO PATIENT INJURY WAS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE HAD SHOWED NO DISPOSABLE CLAMP ATTACHED. NO PATIENT INJURY WAS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE HAD NO DISPOSABLE CLAMP ATTACHED. NO PATIENT INJURY WAS REPORTED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT THIS SMITHS MEDICAL CADD LEGACY PLUS PUMP EXHIBITED NO DISPOSABLE CLAMP ATTACHED. NO ADVERSE EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1246284 CADD LEGACY PLUS PUMP PUMP,INFUSION FRN ST PAUL 6500 10610586019647

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown