BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD® CADD-PRIZM® VIP SYSTEM

    MDR report key: 7733339 · Received July 30, 2018

    Report

    Report Number
    3012307300-2018-02944
    Event Type
    Malfunction
    Date Received
    July 30, 2018
    Date of Event
    May 5, 2018
    Report Date
    September 21, 2018
    Manufacturer
    SMITHS MEDICAL, ASD, INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE CADD® CADD-PRIZM® VIP SYSTEM WAS RETURNED FOR ANALYSIS. THE CUSTOMER'S REPORTED PROBLEM WAS "REOCCURRING LEC 10040 IN HISTORY, LEC 10104, 10102". A VISUAL INSPECTION FOUND THE PUMP TO BE IN GOOD PHYSICAL CONDITION. EVIDENCE OF REPORTED PROBLEM IN EVENT LOG WAS NOT AVAILABLE. OBSERVED THE PUMP DISPLAYING AN ERROR CODE "10104" ALARMING MESSAGE WHEN A BATTERY IS INSERTED DURING THE INVESTIGATION. RETURNED PUMP CHECK AND FOUND MISSING ALL LABELS. THE "REOCCURRING LEC 10040 IN HISTORY, LEC 10104, 10102" ISSUES WERE CAUSED BY CUSTOMER DAMAGE. REINSTALLED BOOT AND SOFTWARE APPLICATIONS AND SOLVED ALL ISSUES. WHAT CAUSED THE REPORTED PROBLEM WAS DETERMINED TO BE CUSTOMER DAMAGE. WHO CAUSED THE REPORTED PROBLEM WAS DETERMINED TO BE THE CUSTOMER.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CADD® CADD-PRIZM® VIP SYSTEM HAD A RECURRING LEC 10040 IN HISTORY, LEC 10104, 10102. UNKNOWN IF THERE WAS PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED STATING THAT NO PATIENT WAS INVOLVED AND NO MEDICAL INTERVENTION WAS THEREFORE REQUIRED. THE CUSTOMER ALSO PROVIDED THE EVENT DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    574082 CADD® CADD-PRIZM® VIP SYSTEM PUMP, INFUSION FRN SMITHS MEDICAL, ASD, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1