BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIVANTAGE DH

    MDR report key: 7947147 · Received October 9, 2018

    Report

    Report Number
    1518293-2018-00039
    Event Type
    Malfunction
    Date Received
    October 9, 2018
    Date of Event
    September 11, 2018
    Report Date
    September 11, 2018
    Manufacturer
    LIEBEL-FLARSHEIM
    Product Code
    IZQ
    PMA / PMN Number
    K063503
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    OVERALL INVESTIGATION SUMMARY IS AS FOLLOWS: INCIDENT: EXTRAVASATION EVENT. INSPECTION OF EQUIPMENT REQUESTED. REGIONAL SERVICE COMPLETED GENERAL INSPECTION OF INJECTOR, CONDUCTED PERFORMANCE TESTS ACCORDING TO PROTOCOL AND VERIFIED FLOW RATE & PRESSURE LIMITS WERE WITHIN PERMITTED RANGE. SERVICE STATED THE "REPORTED PROBLEM IS ATTRIBUTABLE TO BAD CONNECTION TO PATIENT. NO PRESSURE PROBLEMS FOUND. EQUIPMENT IS OPERATIONAL." THE INJECTOR DOES NOT HAVE THE CAPABILITY TO PREVENT OR DETECT AN EXTRAVASATION (INFILTRATION). HOWEVER, PRECAUTIONS TO MINIMIZE AN EXTRAVASATION ARE PROVIDED IN THE OPERATOR'S MANUAL. ADDITIONALLY, DESCRIBED IN THE MANUAL ARE I.V. SITE PATENCY CHECK TECHNIQUES, INCLUDING A MANUAL METHOD AND ANOTHER USING A PATENCY KEY IN THE SETUP SCREEN. CTS HISTORY SEARCH SHOWS NO OTHER SIMILAR ISSUES WITH THIS UNIT. ROOT/PROBABLE CAUSE CODE IS AS FOLLOWS: PERSONNEL - PERFORMANCE - FAILED TO FOLLOW PROCEDURE - SERVICE STATED THE "REPORTED PROBLEM IS ATTRIBUTABLE TO BAD CONNECTION TO PATIENT. NO PRESSURE PROBLEMS FOUND. EQUIPMENT IS OPERATIONAL." NO FURTHER INVESTIGATION NEEDED AT THIS TIME. QA WILL CONTINUE TO MONITOR AND TREND FOR SIMILAR ISSUES. NO CAPA AT THIS TIME, THESE TRENDS AND ISSUES ARE REPORTED ON DURING QUALITY METRICS REVIEWS AND DURING THE MANAGEMENT REVIEW MEETINGS TO CONSIDER INPUT FOR CORRECTIVE ACTION. DISPOSITION SUMMARY IS AS FOLLOWS: SERVICE CONDUCTED PERFORMANCE AND VERIFIED FLOW RATE & PRESSURE LIMITS WERE WITHIN PERMITTED RANGE. SERVICE STATED THE "REPORTED PROBLEM IS ATTRIBUTABLE TO BAD CONNECTION TO PATIENT. NO PRESSURE PROBLEMS FOUND. EQUIPMENT IS OPERATIONAL."

    Description of Event or Problem · 1

    THIS INCIDENT WAS REPORTED BY A DISTRIBUTOR ON (B)(4) 2018, AS AN LFI OPTIVANTAGE EXTRAVASATION AND AN INSPECTION OF THE DEVICE WAS REQUESTED. THE REPORTER STATED THAT THIS EVENT OCCURRED DURING A PROCEDURE, WHICH WAS NOT COMPLETED, AND RESULTED IN THE INJURY OF A PATIENT. THERE WAS NO ERROR CODES THAT PRESENTED DURING THE INCIDENT. A GENERAL INSPECTION OF THE INJECTOR WAS COMPLETED BY REGIONAL SERVICE, INCLUDING PERFORMANCE TESTS ACCORDING TO PROTOCOL, VERIFIED FLOW RATE AND PRESSURE LIMITS WERE WITHIN RANGE PERMITTED. THE REPORTED PROBLEM IS ATTRIBUTED TO BAD CONNECTION TO PATIENT, AND NO PRESSURE PROBLEMS WERE FOUND, DEEMING THE EQUIPMENT AS OPERATIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787019 OPTIVANTAGE DH OPTIVANTAGE DH IZQ LIEBEL-FLARSHEIM 844001

    Patients

    Seq Age Sex Outcome Treatment
    1