BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERELINK ICP MONITOR

    MDR report key: 8931988 · Received August 26, 2019

    Report

    Report Number
    1226348-2019-00367
    Event Type
    Malfunction
    Date Received
    August 26, 2019
    Date of Event
    August 5, 2019
    Report Date
    August 5, 2019
    Manufacturer
    RAYNHAM
    Product Code
    GWM
    PMA / PMN Number
    K183406
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A DHR REVIEW, TRENDING, RISK ASSESSMENT, AND FAILURE ANALYSIS WERE PERFORMED AS PART OF THE COMPLAINT EVALUATION, AND CAN CONFIRM THE FAILURE MODE FOR THE CERELINK MONITOR PRODUCT LINE. ALL CERELINK MONITORS HAVE BEEN RETURNED TO INTEGRA LIFESCIENCES OR THE SUPPLIER TO FURTHER INVESTIGATE THE FAILURES, AND ADDITIONAL INFORMATION AND ROOT CAUSE WILL BE INVESTIGATED UNDER A CAPA. 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)(6) , DIRECTOR OF REGULATORY PROGRAMS, OFFICE OF PRODUCT EVALUATION AND QUALITY AND (B)(6) , ASSISTANT DIRECTOR, MDR TEAM, OFFICE OF PRODUCT EVALUATION AND QUALITY ON JULY 8-9, 2020 TO REPORT THESE ISSUES REGARDING MDR REPORTS.

    Description of Event or Problem · 0

    N/A.

    Additional Manufacturer Narrative · 1

    ATTEMPTS ARE BEING MADE TO OBTAIN ADDITIONAL INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CERELINK MICROSENSOR INSERTED AT APPROX 1AM. SENSOR ZEROED AS PER REQUIRED PROCESS. INITIAL ICP READINGS WERE 6-10 MMHG. AT 4.30 AM THE STAFF IN ICU TRIED TO GET THE PATIENT TO SPONTANEOUSLY BREATH UP, THE ICP PRESSURE ROSE TO 32 MMHG AND THEN PLUNGED TO -50 MMHG. THE STAFF TURNED THE CERELINK ICP MONITOR OFF. CURRENTLY THE CERELINK MICROSENSOR REMAINS IMPLANTED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724047 CERELINK ICP MONITOR ICP MONITOR-CERELINK GWM RAYNHAM

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR