BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERELINK ICP PROBE 1L M BOLT

    MDR report key: 18697907 · Received February 13, 2024

    Report

    Report Number
    3013886523-2024-00041
    Event Type
    Injury
    Date Received
    February 13, 2024
    Report Date
    July 19, 2024
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    GWM
    UDI-DI
    10381780520689
    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 RETURNED FOR EVALUATION: DHR - LOT 6896058 SN (B)(6) MET SPECIFICATIONS WHEN RELEASED FAILURE ANALYSIS - THE ISSUE OF THE COMPLAINT WAS NOT CONFIRMED: CATHETER STRETCHED 92CM ¿ 94.2CM FROM CONNECTOR. CERELINK MONITOR ACCEPTABLE, ICP EXPRESS READ 499. THE DEVICE PASSED ELECTRONIC, NOISE, LINEARITY/HYSTERESIS AND SIGNAL DRIFT TESTS. ROOT CAUSE - NO EXACT ROOT CAUSE COULD BE DETERMINED AS THE TECHNICIAN COULD NOT CONFIRM ANY PROBLEM WITH THE DEVICE AT THE TIME OF INVESTIGATION. HOWEVER, THE POSSIBLE ROOT CAUSE FOR THE ISSUE REPORTED BY THE CUSTOMER COULD BE DUE TO A CHANGE IN THE HOSPITAL ENVIRONMENT (ELECTRICAL GRID, EQUIPMENT BEING USED NEAR THE ICP SENSOR OR DIRECTLINK, CABLE MANAGEMENT).

    Description of Event or Problem · 0

    3 OF 3 REPORTS. OTHER MFG REPORT NUMBERS: 3013886523-2024-00039 3013886523-2024-00040. A FACILITY REPORTED A CERELINK SENSOR (B)(6) HAD VERY HIGH PRESSURE (300), AND THEN A FLAT LINE WAS SEEN FIVE HOURS AFTER PLACEMENT. THE SENSOR WAS REMOVED AND REPLACED. THE SECOND SENSOR WORKED FOR 11 HOURS, THEN SUDDENLY, FLAT LINE. IT WAS EXPLANTED AND MONITORING STOPPED. THE SENSORS WERE CONNECTED TO DIRECTLINK MODULE (ID 826828).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    805418 CERELINK ICP PROBE 1L M BOLT ICP MICRSOSENSORS - CERELINK GWM INTEGRA LIFESCIENCES MANSFIELD 10381780520689

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown