BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PMO COMBINED PROBE CONTAINING BOTH OXYGEN AND TEMP.

    MDR report key: 9250602 · Received October 29, 2019

    Report

    Report Number
    9612007-2019-00042
    Event Type
    Malfunction
    Date Received
    October 29, 2019
    Date of Event
    September 23, 2019
    Report Date
    October 3, 2019
    Manufacturer
    INTEGRA NEUROSCICENCS IMPLANTS SA
    Product Code
    GWM
    PMA / PMN Number
    K040235
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 0

    THE LICOX PROBE REF CC1P1, SN (B)(6), LOT 212222, THE SMART CARD AND IP1 INTRODUCER WERE RECEIVED. VISUAL INSPECTION REVEALED NO ANOMALY. THE LICOX PROBE WAS CONNECTED TO THE MONITOR AND A FUNCTIONALITY TEST IN AIR WAS PERFORMED DURING 24H: OXYGEN PRESSURE VALUE WAS FOUND AT 141.2MMHG INSTEAD OF 142 TO 159MMHG, CLOSE TO THE LOWER SPECIFICATION LIMIT. PROBE WAS IMMERGED IN WATER AND TESTED TO CHECK STABILITY: PROBE IS STABLE AND FUNCTIONAL. PROBE WAS TESTED IN A SOLUTION WITH OXYGEN PRESSURE AT 0 MMHG: MEASURE OF OXYGEN VALUE MUST DECREASE OF 90% OF INITIAL VALUE IN LESS THAN 3 MINUTES: TEST PASSED. EACH LICOX PROBE IS TESTED AT TIME OF MANUFACTURING AND THIS LICOX PROBE, SN 234, WAS FOUND WITHIN SPECIFICATIONS, AS PER THE DEVICE HISTORY RECORDS. THE COMPLAINT IS NOT VERIFIED BY THE INVESTIGATION, PROBE IS FUNCTIONAL; THE ABNORMALLY HIGH VALUES WERE NOT OBSERVED THROUGH DIFFERENT TESTS. THE EXACT CAUSE OF THE REPORTED ABNORMALLY HIGH OXYGEN PRESSURE VALUES COULD NOT BE DETERMINED BY THE INVESTIGATION. DEVICE IDENTIFIER (B)(4). BETWEEN 05NOV2019 AND 30JUN2020, APPROXIMATELY 2,200 MDRS SUBMITTED ELECTRONICALLY BY INTEGRA LIFESCIENCES VIA TRACKWISE, INTEGRA'S COMPLAINT HANDLING SYSTEM, WERE NOT RECEIVED BY CDRH DUE TO A COMPUTER SYSTEM ISSUE. WITHIN THIS TIME PERIOD, AN ERROR WITH INTEGRA'S MIDDLEWARE, WHICH FACILITATES COMMUNICATIONS BETWEEN TRACKWISE AND THE FDA SYSTEM, CAUSED THE COMPLAINT RECORDS TO CLOSE AND INDICATE WE HAD RECEIVED AN ACKNOWLEDGEMENT 3 FROM THE FDA WHEN WE HAD NOT. INTEGRA INTERPRETED THE ACKNOWLEDGEMENT AS A SUCCESSFUL SUBMISSION; HOWEVER, SUBSEQUENT INVESTIGATION REVEALED THE ACKNOWLEDGEMENT 3 RECEIVED WAS FROM OUR MIDDLEWARE AND NOT FROM THE FDA (THESE ACKNOWLEDGEMENTS HAVE BEEN RETAINED AS PART OF THE DOCUMENTATION OF THE MDR). THE MALFUNCTION WAS RELATED TO THE RELOCATION OF THE TRACKWISE APPLICATION TO A NEW DATA CENTER DURING THE TRANSITION OF INTEGRA'S CORPORATE HEADQUARTERS FROM PLAINSBORO, NJ TO PRINCETON, NJ. PREVIOUSLY, INTEGRA HAD BEEN SUCCESSFULLY RECEIVING ACKNOWLEDGEMENTS 1, 2, AND 3 FROM THE FDA, AND OUR RECORDS REFLECT THESE ACKNOWLEDGEMENTS, INCLUDING THE DATE AND TIME STAMPS. CAPA PR 229048 AND NC 20-011 HAVE BEEN OPENED BY INTEGRA TO FURTHER INVESTIGATE THE NONCONFORMANCE AND DEVELOP A CORRECTIVE ACTION PLAN. THE MIDDLEWARE ERROR HAS BEEN CORRECTED, AND INTEGRA HAS FILED MDRS SINCE THE CORRECTION AND VERIFIED THAT THE APPROPRIATE ACKNOWLEDGEMENTS HAVE BEEN RECEIVED FROM THE FDA. INTEGRA IS RESUBMITTING ALL IMPACTED MDR REPORTS FOR THE TIME PERIOD 05NOV2019 THROUGH 30JUN2020. INTEGRA LIFESCIENCES CONTACTED (B)(4) OFFICE OF PRODUCT EVALUATION AND QUALITY ON JULY 8-9, 2020 TO REPORT THESE ISSUES REGARDING MDR REPORTS.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT YET RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE PLANT INVESTIGATION IS IN PROGRESS AND A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CC1P1 PMO COMBINED PROBE WAS CORRECTLY PLACED UPON SCANNER BUT THE DEVICE OFTEN READ A VALUE AT 474 ON (B)(6) 2019. "INDUCTED ERROR" WAS REPORTED. CARING OF THE PATIENT WAS DELAYED. THEY DID NOT INSERT ANOTHER PROBE TO FOLLOW THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1046689 PMO COMBINED PROBE CONTAINING BOTH OXYGEN AND TEMP. LICOX BOLTS CATHETERS & KITS GWM INTEGRA NEUROSCICENCS IMPLANTS SA 212222

    Patients

    Seq Age Sex Outcome Treatment
    1