BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERELINK ICP PROBE BASIC KIT

    MDR report key: 15329879 · Received August 31, 2022

    Report

    Report Number
    3013886523-2022-00402
    Event Type
    Injury
    Date Received
    August 31, 2022
    Date of Event
    August 14, 2022
    Report Date
    October 12, 2022
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    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 MICROSENSOR (ID 826850) WAS RETURNED FOR EVALUATION. DEVICE HISTORY RECORD (DHR) - THE PRODUCT 826850 FOR LOT 6113498 (SN 133227), AND THE LOT MET SPECIFICATIONS WHEN RELEASED. FAILURE ANALYSIS - THE ISSUE OF THE COMPLAINT HAS BEEN CONFIRMED: CATHETER MATERIAL STRETCHED AT 30.3 CM FROM CONNECTOR AND CRIMPED/PINCHED 11.5CM FROM CASE. INTERNAL WIRES BROKEN. CERELINK MONITOR READING WAS UNACCEPTABLE; ICP EXPRESS READ "NO TRANSDUCER DETECTED". NO TESTING WAS POSSIBLE. BASED ON THE FAILURE ANALYSIS, THE ROOT CAUSE COULD BE DETERMINED AS A MISHANDLING OF THE CATHETER.

    Description of Event or Problem · 0

    A FACILITY REPORTED THE MONITOR WAS DETECTING AN ERROR FORM THE CERELINK MICROSENSOR (ID 826850) . TWO MONITORS WERE CONNECTED TO THE SENSOR AND THE ERROR PERSISTED; THEREFORE, THE SENSOR WAS REMOVED AND MONITORING WAS DISCONTINUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2180135 CERELINK ICP PROBE BASIC KIT ICP MICRSOSENSORS - CERELINK GWM INTEGRA LIFESCIENCES SWITZERLAND SAR 826850 133227 10381780520672

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown