BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIVANTAGE DH

    MDR report key: 16857834 · Received May 2, 2023

    Report

    Report Number
    1518293-2023-00009
    Event Type
    Malfunction
    Date Received
    May 2, 2023
    Report Date
    April 4, 2023
    Manufacturer
    LIEBEL-FLARSHEIM
    Product Code
    IZQ
    PMA / PMN Number
    K063503
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OVERALL INVESTIGATION SUMMARY: A COMPLAINT WAS RECEIVED ON OPTIVANTAGE INJECTOR 844001 SERIAL NUMBER C0612B507X ALLEGING AN ERROR OX2046/OX0002/OX0006/OX0000. THE INJECTOR REPORTEDLY REQUIRED 25 MINUTES TO RESTART DURING A REPORTEDLY LIFE-THREATENING SITUATION. LATER INFORMATION WAS RECEIVED CONFIRMING THAT THE PATIENT DID NOT HAVE ANY NEGATIVE EFFECTS DUE TO THE DELAY. THE CUSTOMER DID NOT WANT THIS UNIT TO BE SERVICED AS THE CUSTOMER IS PURCHASING A NEW INJECTOR IN THE NEAR FUTURE. IN THE INTERIM, THE CUSTOMER WILL CONTINUE TO USE THIS INJECTOR AS IT REMAINS IN A USABLE STATE. AS A PRECAUTION TO MITIGATE A POTENTIAL RECURRENCE, A LOANER INJECTOR WAS PROVIDED. AS THE CUSTOMER DID NOT ACCEPT SERVICE ON THE COMPLAINT UNIT, AN INVESTIGATION ON THE SPECIFIC UNIT WAS NOT POSSIBLE. INSTEAD, A DOCUMENTATION REVIEW WAS EXECUTED. THE UNITS' DEVICE HISTORY RECORD (DHR) DID NOT HAVE ANY RELATED ISSUES RECORDED. THE COMPLAINT HISTORY FOR THIS UNIT WAS REVIEWED AND FOUND THAT THIS UNIT WAS UPGRADED TO SOFTWARE VERSION 6.06 IN 2022 AND ALSO REPLACED THE POWERHEAD TOUCHSCREEN PART NUMBER 844364 AFTER THE UPGRADE. FURTHER INVESTIGATION IS NOT POSSIBLE AT THIS TIME. WHILE A DEFINITIVE ROOT CAUSE CANNOT BE IDENTIFIED, DISCUSSIONS WITH THE DESIGN AND ENGINEERING GROUP HAS IDENTIFIED THAT A POTENTIAL CAUSE COULD BE IN THE CONSOLE PRINTED CIRCUIT BOARDS AS THE CONSOLE WAS NOT PROVIDING INFORMATION TO THE POWERHEAD BEFORE THE REQUEST IN THE 0026 ERROR TIMED OUT (EXPIRED). THERE ARE NO CORRECTIVE OR PREVENTIVE ACTIONS WARRANTED AT THIS TIME. THE COMPLAINT CONDITION COULD NOT BE CONFIRMED DUE TO THE CUSTOMER'S WISHES. IMPACT ASSESSMENT SUMMARY: THERE IS NO NEGATIVE IMPACT TO THE PATIENT OR USERS DUE TO THIS COMPLAINT. IMDRF CODES = B17, B14; C19, C040101; D14, D1105. ROOT / PROBABLE CAUSE SUMMARY: SEE INVESTIGATION SUMMARY FOR DETAILS. NO DEFINITIVE ROOT CAUSE WAS ABLE TO BE DETERMINED. THERE IS NO NEED FOR A CAPA AT THIS TIME. THESE ISSUES ARE REPORTED UPON DURING MANAGEMENT REVIEW TO CONSIDER INPUT FOR CORRECTIVE ACTIONS. QA WILL CONTINUE TO MONITOR AND TREND FOR SIMILAR ISSUES. DISPOSITION SUMMARY: WHILE THE UNIT WAS NOT CLEARED FOR USE BY REGIONAL SERVICE, THE CUSTOMER IS CONTINUING TO USE THE INJECTOR. A LOANER INJECTOR WAS ALSO PROVIDED TO MITIGATE THE EFFECTS IN CASE OF RECURRENCE OF THE COMPLAINT CONDITION.

    Description of Event or Problem · 0

    THIS CASE WAS REPORTED BY A FACILITY IN (B)(4) NETHERLANDS ON (B)(6) 2023. A COMPLAINT WAS RECEIVED ON OPTIVANTAGE INJECTOR 844001, SERIAL NUMBER (B)(6), ALLEGING AN ERROR OX2046/OX0002/OX0006/OX0000. THE INJECTOR REPORTEDLY REQUIRED 25 MINUTES TO RESTART DURING A REPORTEDLY LIFE-THREATENING SITUATION. LATER INFORMATION WAS RECEIVED CONFIRMING THAT THE PATIENT DID NOT HAVE ANY NEGATIVE EFFECTS DUE TO THE DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1818076 OPTIVANTAGE DH OPTIVANTAGE DH IZQ LIEBEL-FLARSHEIM 844001

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown