BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD-LEGACY PLUS PUMP

    MDR report key: 13527758 · Received February 14, 2022

    Report

    Report Number
    3012307300-2022-03339
    Event Type
    Malfunction
    Date Received
    February 14, 2022
    Report Date
    February 14, 2022
    Manufacturer
    NULL
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6). DEVICE EVALUATION: ONE SMITHS MEDICAL CADD LEGACY PLUS, MDL 6500, WAS RETURNED FOR ANALYSIS IN USED CONDITION. VISUAL INSPECTION SHOWED NO DAMAGE TO THE PUMP. . REVIEW OF THE EVENT HISTORY LOG NO ISSUES RELATED TO THE CUSTOMER PROBLEM WERE FOUND HOWEVER DATE AND TIME DISCREPANCIES AND CASSETTE NOT ATTACHED (NDA) AND OCCLUSION ALARM WERE NOTED. FUNCTIONAL TESTING WAS PERFORMED AND WAS UNABLE TO CONFIRM THE PROBLEM SINCE ACCURACY TESTING WAS WITHIN SPECIFICATION WITH NO ALARM. THE INVESTIGATOR REPLACED THE MICROPROCESSOR BOARD AND DOWNSTREAM SENSOR AS PREVENTIVE MEASURES FOR THE DATE AND TIME DISCREPANCIES AND NDA ISSUES OBSERVED IN THE HISTORY LOG. THE INVESTIGATION WAS UNABLE TO REPRODUCE THE PROBLEM, THE COMPLAINT ALLEGATION WAS NOT CONFIRMED.

    Additional Manufacturer Narrative · 0

    REPORT SOURCE: (B)(6). DEVICE EVALUATION: ONE SMITHS MEDICAL CADD LEGACY PLUS, MDL 6500, WAS RETURNED FOR ANALYSIS IN USED CONDITION. VISUAL INSPECTION SHOWED NO DAMAGE TO THE PUMP. . REVIEW OF THE EVENT HISTORY LOG NO ISSUES RELATED TO THE CUSTOMER PROBLEM WERE FOUND HOWEVER DATE AND TIME DISCREPANCIES AND CASSETTE NOT ATTACHED (NDA) AND OCCLUSION ALARM WERE NOTED. FUNCTIONAL TESTING WAS PERFORMED AND WAS UNABLE TO CONFIRM THE PROBLEM SINCE ACCURACY TESTING WAS WITHIN SPECIFICATION WITH NO ALARM. THE INVESTIGATOR REPLACED THE MICROPROCESSOR BOARD AND DOWNSTREAM SENSOR AS PREVENTIVE MEASURES FOR THE DATE AND TIME DISCREPANCIES AND NDA ISSUES OBSERVED IN THE HISTORY LOG. THE INVESTIGATION WAS UNABLE TO REPRODUCE THE PROBLEM, THE COMPLAINT ALLEGATION WAS NOT CONFIRMED.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED INDICATING THAT A CADD LEGACY PLUS, MDL 6500, PUMP MEDICAL FLUID INFUSED WAS LESS THAN THE SET VOLUME. NO ADVERSE PATIENT EFFECTS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED INDICATING THAT A CADD LEGACY PLUS, MDL 6500, PUMP MEDICAL FLUID INFUSED WAS LESS THAN THE SET VOLUME. NO ADVERSE PATIENT EFFECTS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    558805 CADD-LEGACY PLUS PUMP PUMP, INFUSION FRN 6500

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown