BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERELINK ICP PROBE BASIC KIT

    MDR report key: 14935941 · Received July 6, 2022

    Report

    Report Number
    3013886523-2022-00311
    Event Type
    Injury
    Date Received
    July 6, 2022
    Report Date
    September 28, 2022
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    GWM
    UDI-DI
    10381780520672
    PMA / PMN Number
    K173192
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    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

    THE CERELINK SENSOR WAS NOT RETURNED FOR EVALUATION 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 UNSTABLE SENSOR PERFORMANCE OR INCORRECT SELECTION OF SEMICONDUCTOR COMPONENTS. 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.

    Description of Event or Problem · 0

    4 OF 5 REPORTS. OTHER MFG REPORT NUMBERS: 3013886523-2022-00309, 3014334038-2022-00149, 3013886523-2022-00310, 3014334038-2022-00150. A FACILITY REPORTED PATIENT HAD CERELINK ICP SENSOR INSERTED ON FRIDAY (B)(6) 2022 FOR ELECTIVE ICP MONITORING. ON SATURDAY (B)(6) 2022 AT NIGHT THE CERELINK ICP CABLE (826945) FAILED, ON SUNDAY (B)(6) 2022, A NEW MONITOR AND CABLE WERE ATTACHED TO THE ORIGINAL SENSOR BUT THEY HAD THE SAME CABLE FAILURE. A NEW SENSOR WAS THEN INSERTED INTO THE PATIENT BUT RE-ATTACHED TO THE ALREADY FAILED CABLE. THE MESSAGE ON THE MONITOR WAS NOW "SENSOR NOT DETECTED". THEY TRIED WITH ONE MORE MONITOR AND CABLE, WHICH DISPLAYED THE SAME MESSAGE. MEDICAL STAFF GOT IN COMMUNICATION WITH THE INTEGRA SALES REPRESENTATIVE AND EXPLAINED WHAT HAD HAPPENED AND WHAT THEY HAD DONE SO FAR. THE INTEGRA SALES REPRESENTATIVE EXPLAINED THAT IF THE SENSOR WAS NOT DETECTED THEY NEEDED TO REPLACE IT, BUT WITH IT THEY ALSO NEEDED TO PLUG THE NEW SENSOR IN, WITH A NEW MONITOR AND CABLE. THIS WAS DONE AND THE ICP WAS READING AS NORMAL AGAIN. ON TUESDAY (B)(6) 2022 THE CABLE FAILED AGAIN AND THEY SWITCHED THE MONITOR. THE CABLE WAS SWAPPED FOR A NEW ONE AND IT WAS READING NORMAL AND STABLE AGAIN.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2396714 CERELINK ICP PROBE BASIC KIT ICP MICRSOSENSORS - CERELINK GWM INTEGRA LIFESCIENCES MANSFIELD 826850 10381780520672

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown