BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD LEGACY PLUS PUMP

    MDR report key: 14603124 · Received June 6, 2022

    Report

    Report Number
    3012307300-2022-10790
    Event Type
    Malfunction
    Date Received
    June 6, 2022
    Report Date
    September 20, 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

    THE DEVICE WAS RETURNED TO SMITHS/ICU MEDICAL.

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: B5: ADDITIONAL INFORMATION RECEIVED BY SMITHS MEDICAL/ICU ON 3-JUN-2022 VIA EMAIL AND ATTACHED TO COMPLAINT OBJECT: THE ISSUE WAS NOTED DURING USE WITH A PATIENT. THERE WAS NO PATIENT INJURY AS A RESULT. NO FURTHER INFORMATION IS AVAILABLE FROM THE CUSTOMER.

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: B5: ADDITIONAL INFORMATION RECEIVED BY SMITHS MEDICAL/ICU ON 3-JUN-2022 VIA EMAIL AND ATTACHED TO COMPLAINT OBJECT: THE ISSUE WAS NOTED DURING USE WITH A PATIENT. THERE WAS NO PATIENT INJURY AS A RESULT. NO FURTHER INFORMATION IS AVAILABLE FROM THE CUSTOMER.

    Additional Manufacturer Narrative · 0

    H10: DEVICE EVALUATION: ONE PUMP SAMPLE WAS RECEIVED AT MANUFACTURING. VISUAL AND FUNCTIONAL EVALUATION WAS PERFORMED ON THE RETURNED SAMPLE. VISUAL INSPECTION CONFIRMED THAT THE PHYSICAL CONDITION WAS ALL INTACT UPON RECEIPT. FUNCTIONAL TESTING INCLUDED RUNNING THE PUMP 2 MINUTES 30.38 SECONDS AND THE PUMP ALARMED AFTER 2 MINUTES, 30.03 SECONDS. A BATTERY LOSS ALARM TEST WAS PERFORMED AND PASSED. AFTER RUNNING THREE ACCURACY TESTS, THE PUMP WAS FOUND TO BE OVER DELIVERING TO THE MANUFACTURING SPECIFICATIONS. ERROR CODES FOR HIGH PRESSURE AND NO DISPOSABLE MESSAGES WERE FOUND IN THE EVENT HISTORY LOG. RESULTS: THE CUSTOMER REPORTED PROBLEM WAS DUPLICATED AS THE INVESTIGATION CONFIRMED A FAILED ACCURACY TEST ISSUE DURING THE INVESTIGATION. ROOT CAUSE OF THE REPORTED ISSUE WOULD BE ATTRIBUTED TO INACCURATE DELIVERY FROM THE PUMP DUE TO THE EXPULSOR ASSEMBLY. THE EXPULSOR ASSEMBLY WAS REPLACED. A DEVICE HISTORY RECORD 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., CORRECTED DATA: D5: CORRECTION: OPERATOR OF DEVICE: UNKNOWN TO DATE, E4: CORRECTION: INITIAL REPORTER SENT TO FDA: UNKNOWN TO DATE.

    Description of Event or Problem · 0

    ORACLE RO 1233070: IT WAS REPORTED THAT THE PUMP FAILED AN ACCURACY TEST. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2196177 CADD LEGACY PLUS PUMP PUMP, INFUSION FRN ST PAUL 6500 10610586019647

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown