BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN CERELINK

    MDR report key: 14338138 · Received May 9, 2022

    Report

    Report Number
    3013886523-2022-00185
    Event Type
    Death
    Date Received
    May 9, 2022
    Report Date
    July 7, 2022
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    GWM
    PMA / PMN Number
    NI
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    CERELINK SENSOR WAS NOT RETURNED FOR EVALUATION (DISCARDED BY CUSTOMER) AND LOT NUMBER INFORMATION HAS NOT BEEN PROVIDED; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED, AND MANUFACTURING RECORDS COULD NOT BE REVIEWED. THE CAUSE(S) OF THE DIFFICULTY REPORTED BY THE CUSTOMER COULD NOT BE DETERMINED; HOWEVER, THE POSSIBLE ROOT CAUSE FOR THIS ISSUE REPORTED BY THE CUSTOMER COULD BE DUE TO EXCESSIVE PRESSURE APPLIED TO PRODUCT. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED. THE CAUSE OF THE DEATH WAS NOT PROVIDED BY THE HOSPITAL; HOWEVER, A MEDICAL ASSESSMENT WAS PERFORMED BY AN INTEGRA MEDICAL SAFETY SPECIALIST AND CONCLUDED THE FOLLOWING: BASED ON THE COMPLAINT INFORMATION RECEIVED TO DATE, THE PRODUCT AND PRODUCT PERFORMANCE ISSUE DOES NOT APPEAR TO BE ASSOCIATED WITH THE PATIENT¿S DEATH. THE CUSTOMER DID NOT OPT TO INSERT A DIFFERENT CERELINK SENSOR WHEN THE REPORTED ISSUE OCCURRED BUT OPTED TO MONITOR THE PATIENT¿S INTRACRANIAL PRESSURE (ICP) USING ANOTHER SYSTEM. THE CUSTOMER DID NOT INDICATE A SENSOR OR CABLE ERROR HAD OCCURRED. ADDITIONAL INFORMATION HAD BEEN REQUESTED BUT THE CUSTOMER RESPONDED THAT NO ADDITIONAL INFORMATION ABOUT THE PATIENT¿S DEATH WILL BE GIVEN. AT THIS TIME, IT IS UNKNOWN WHETHER THE PROPER ZEROING AND INSERTION PROCESS WAS FOLLOWED PER IFU. IN ADDITION, THE IFU CAUTIONS THE USER TO AVOID DIRECT CONTACT WITH THE TRANSDUCER (SENSING ELEMENT) AT THE TIP OF THE DEVICE. WHEN HANDLING THE ICP SENSOR, CARE MUST BE TAKEN AT ALL TIMES TO PROTECT THE TIP FROM IMPACT AS DAMAGE COULD RESULT. EVALUATION OF THE DEVICE IS NOT POSSIBLE SINCE THE CUSTOMER REPORTED THAT THE DEVICE WAS THROWN OUT.

    Description of Event or Problem · 0

    A FACILITY REPORTED THAT AFTER ZEROING AND INSERTION, A CERELINK MICROSENSOR HAD NO READING VALUE. THE MONITORING WAS DISCONTINUED, THERE WAS MORE MANIPULATION OF THE EVD SYSTEM AND ANOTHER MONITORING SYSTEM WAS USED. PATIENT DIED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1840381 UNKNOWN CERELINK ICP MICRSOSENSORS - CERELINK GWM INTEGRA LIFESCIENCES MANSFIELD

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Death