BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD-LEGACY PLUS AMBULATORY INFUSION SYSTEM

    MDR report key: 14658848 · Received June 10, 2022

    Report

    Report Number
    3012307300-2022-11604
    Event Type
    Malfunction
    Date Received
    June 10, 2022
    Report Date
    August 24, 2022
    Manufacturer
    ST PAUL
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (CATALOG NUMBER AND UDI), MODEL #, AND PMA/510K ARE UNKNOWN. NO PRODUCT INFORMATION HAS BEEN PROVIDED TO DATE. A MANUFACTURING DEVICE HISTORY (DHR) REPORT REVIEW WAS NOT PERFORMED BECAUSE THE RESULTS OF THE COMPLAINT INVESTIGATION DID NOT INDICATE A PROBLEM WITH THE MANUFACTURE OF THE DEVICE. NO CAUSES OR POTENTIAL CAUSES OF THE CUSTOMER'S REPORTED PROBLEM WERE FOUND DURING THE REVIEW OF SERVICE AND REPAIR RECORDS. THE DEVICE IS OUT OF WARRANTY. THEREFORE, NO MANUFACTURING DHR REVIEW IS NEEDED. ALL LABELS WERE STILL INTACT. NO PHYSICAL DAMAGED WAS FOUND ON THE DEVICE. AS A RESULT OF CHECKING THE LOG, IT CONFIRMED THAT THERE WAS A RECORD OF A CONTINUOUS "HIGH PRESSURE" ALARM. FUNCTION TEST WAS PERFORMED AND PASSED. THE REPRODUCIBILITY OF THE REPORTED EVENT WAS NOT CONFIRMED. THE REPORTED PROBLEM WAS CAUSED BY POSSIBLY THE CATHETER BASED ON CUSTOMER REPORT. AS A PREVENTATIVE MEASURE, THE UPSTREAM SENSOR WAS RE-CALIBRATED.

    Additional Manufacturer Narrative · 0

    OTHER TEXT: H6: EVENT PROBLEM AND EVALUATION CODES: UPDATES NOT REQUIRED., CORRECTED DATA: D4: CORRECTION: CATALOG NUMBER: 21-6500-09. D4: CORRECTION: MODEL NUMBER: 6500.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE USE OF THE PRODUCT, A "HIGH PRESSURE" ALARM WENT OFF. THE CUSTOMER DISCONNECTED THE CONNECTION PART WHERE THE CATHETER AND THE TUBING WERE CONNECTED AND AFTER THAT THE ALARM WAS CLEARED. THE CUSTOMER SUSPECTS THERE WAS AN ANOMALY IN THE CATHETER BUT WANTS THE PUMP CHECKED AS WELL. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2289097 CADD-LEGACY PLUS AMBULATORY INFUSION SYSTEM PUMP, INFUSION FRN ST PAUL 6500

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown