BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD LEGACY PLUS PUMP

    MDR report key: 12305167 · Received August 10, 2021

    Report

    Report Number
    3012307300-2021-08288
    Event Type
    Malfunction
    Date Received
    August 10, 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
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER REPORTED THAT THERE WAS NO DISPOSABLE ALARM. TAMPER SEALS WERE ALL INTACT. PERFORMED VISUAL INSPECTION OF THE PUMP,NDA TESTING. UNABLE TO DETERMINE WHAT CAUSED THE PROBLEM. REPLACED DOWNSTREAM SENSOR.

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: CUSTOMER REPORTED THAT THERE WAS NO DISPOSABLE ALARM. TAMPER SEALS WERE ALL INTACT, FOUND FLUID INGRESSION ON PUMP BY THE CHASSIS BASE OF THE OCCLUSION SENSOR. PERFORMED VISUAL INSPECTION OF THE PUMP, RAN PUMP WITH CUSTOMER RETURNED PROGRAM NDA TESTING UNABLE TO DETERMINE WHAT CAUSED THE PROBLEM. REPLACED DOWNSTREAM SENSOR.

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: CUSTOMER REPORTED THAT THERE WAS NO DISPOSABLE ALARM. TAMPER SEALS WERE ALL INTACT, FOUND FLUID INGRESSION ON PUMP BY THE CHASSIS BASE OF THE OCCLUSION SENSOR. PERFORMED VISUAL INSPECTION OF THE PUMP, RAN PUMP WITH CUSTOMER RETURNED PROGRAM NDA TESTING UNABLE TO DETERMINE WHAT CAUSED THE PROBLEM. REPLACED DOWNSTREAM SENSOR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE HAD NO DISPOSABLE ALARM DURING TESTING. NO PATIENT INJURY WAS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE HAD NO DISPOSABLE ALARM DURING TESTING. NO PATIENT INJURY WAS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE HAD NO DISPOSABLE ALARM DURING TESTING. NO PATIENT INJURY WAS REPORTED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT DURING TESTING OF THIS SMITHS MEDICAL CADD LEGACY PLUS PUMP, THE PUMP EXHIBITED NO DISPOSABLE ALARM. NO PATIENT INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1196261 CADD LEGACY PLUS PUMP PUMP, INFUSION FRN ST PAUL 6500 10610586019647

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown