BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD LEGACY PLUS PUMP

    MDR report key: 9981252 · Received April 21, 2020

    Report

    Report Number
    3012307300-2020-03278
    Event Type
    Malfunction
    Date Received
    April 21, 2020
    Report Date
    May 21, 2020
    Manufacturer
    ST PAUL
    Product Code
    FRN
    UDI-DI
    10610586019647
    PMA / PMN Number
    K982836
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: DEVICE EVALUATION SUMMARY: ONE CADD LEGACY PLUS PUMP WAS RETURNED FOR ANALYSIS. VISUAL INSPECTION OF THE PUMP FOUND A BUBBLE ON THE TOP EDGE OF THE LENS. THE BATTERY COVER WAS MISSING. THE PUMP?S UPPER REAR LABEL HAD BEEN REMOVED. REVIEW OF DEVICE HISTORY DID NOT FIND THE REPORTED EVENT IN THE HISTORY LOG. PUMP WAS TESTED IN USER MODE TO TEST ACCURACY. DURING TESTING THE PUMP GAVE ACCURACY RESULT OF -7.65%. THE RESULT WAS OUTSIDE THE PUBLISHED CUSTOMER SPEC OF +/-6.0%. DURING THE FURTHER INSPECTION OF THE LATCH/LOCK ASSEMBLY, IT WAS REVEALED THAT A GOB OF SILICONE GLUE THAT WAS PREVENTING THE CASSETTE FROM FULLY SEATING. IT WAS ALSO OBSERVED THAT THERE HAD BEEN SOME TAMPERING WITH THE DOWNSTREAM OCCLUSION SENSOR. THERE WAS GLUE AROUND THE CD NUB. THE UPSTREAM SENSOR WAS THE ORIGINAL VERSION (BLACK) BUT THE SEAL HAD YELLOWED. THE REPORTED UNDER DELIVERY ISSUE WAS CAUSED BY THE SILICONE GLUE IN THE LATCH MECHANISM.THE REPORTED FAILED ACCURACY PROBLEM WAS ABLE TO BE DUPLICATED. THE PROBLEM SOURCE OF THE REPORTED EVENT COULD NOT BE IDENTIFIED.

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: DEVICE EVALUATION SUMMARY: ONE CADD LEGACY PLUS PUMP WAS RETURNED FOR ANALYSIS. VISUAL INSPECTION OF THE PUMP FOUND A BUBBLE ON THE TOP EDGE OF THE LENS. THE BATTERY COVER WAS MISSING. THE PUMP?S UPPER REAR LABEL HAD BEEN REMOVED. REVIEW OF DEVICE HISTORY DID NOT FIND THE REPORTED EVENT IN THE HISTORY LOG. PUMP WAS TESTED IN USER MODE TO TEST ACCURACY. DURING TESTING THE PUMP GAVE ACCURACY RESULT OF -7.65%. THE RESULT WAS OUTSIDE THE PUBLISHED CUSTOMER SPEC OF +/-6.0%. DURING THE FURTHER INSPECTION OF THE LATCH/LOCK ASSEMBLY, IT WAS REVEALED THAT A GOB OF SILICONE GLUE THAT WAS PREVENTING THE CASSETTE FROM FULLY SEATING. IT WAS ALSO OBSERVED THAT THERE HAD BEEN SOME TAMPERING WITH THE DOWNSTREAM OCCLUSION SENSOR. THERE WAS GLUE AROUND THE CD NUB. THE UPSTREAM SENSOR WAS THE ORIGINAL VERSION (BLACK) BUT THE SEAL HAD YELLOWED. THE REPORTED UNDER DELIVERY ISSUE WAS CAUSED BY THE SILICONE GLUE IN THE LATCH MECHANISM. THE REPORTED FAILED ACCURACY PROBLEM WAS ABLE TO BE DUPLICATED. THE PROBLEM SOURCE OF THE REPORTED EVENT COULD NOT BE IDENTIFIED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT DURING ANALYSIS, A SMITHS MEDICAL CADD LEGACY PLUS PUMP WAS NOTED TO BE UNDER INFUSING. NO PATIENT WAS INVOLVED IN THIS EVENT. NO ADVERSE EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446205 CADD LEGACY PLUS PUMP PUMP, INFUSION FRN ST PAUL 6500 10610586019647

    Patients

    Seq Age Sex Outcome Treatment
    1