BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERELINK ICP PROBE BASIC KIT

    MDR report key: 14518337 · Received May 26, 2022

    Report

    Report Number
    3013886523-2022-00217
    Event Type
    Malfunction
    Date Received
    May 26, 2022
    Date of Event
    May 8, 2022
    Report Date
    March 22, 2023
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    GWM
    UDI-DI
    10381780520672
    PMA / PMN Number
    K173192
    Product Problem
    Yes
    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 ICP PROBE BASIC KIT (ID 826850) WAS RETURNED FOR EVALUATION. DEVICE HISTORY RECORD (DHR) - LOT 6100417 SN (B)(6) MET SPECIFICATIONS WHEN RELEASED. FAILURE ANALYSIS - THE ISSUE OF THE COMPLAINT WAS NOT CONFIRMED: SLIGHT FILM ON RTV THAT IS NOT PART OF THE MANUFACTURING PROCESS. CATHETER RECEIVED WITH SUTURES AND HAD SLIGHT BENDS. CERELINK MONITOR READING WAS NOT ACCEPTABLE; ICP EXPRESS PASSED WITH READING 790. CLEANED FILM RTV AND CERELINK MONITOR READING WAS ACCEPTABLE; ICP EXPRESS PASSED WITH READING 520. THE DEVICE PASSED ELECTRONIC, NOISE, LINEARITY/HYSTERESIS, AND SIGNAL DRIFT TESTS. THE ROOT CAUSE OF THE ISSUE REPORTED BY CUSTOMER WAS USE RELATED. AFTER CLEANING THE FILM FROM THE RTV, DEVICE PASSED ALL TESTS. NEVERTHELESS, PER THE COMPLAINT BACKGROUND, ERROR MESSAGE ON SCREEN.

    Description of Event or Problem · 0

    THIS IS 1 OF 2 REPORTS LINKED TO MFG REPORT NUMBER: 3014334038-2022-00107. A FACILITY REPORTED A CERELINK ICP PROBE BASIC KIT (ID 826850) WAS IMPLANTED IN A PATIENT ON (B)(6) 2022 AT 12:18PM (PARENCHYMAL). HOURS LATER AFTER IMPLANTATION, THE CERELINK MONITOR (ID 826820) STARTED TO SHOW A MEAN ICP VALUE OF NEGATIVE 50 AND GAVE SENSOR/CABLE ERROR MESSAGE. THE PATIENT HAD NOT BEEN TRANSPORTED OR MOVED BETWEEN THE TIME THE SENSOR WAS PLACED AND WHEN THE ISSUE OCCURRED. THE MONITOR WAS PLUGGED INTO THE WALL AND WAS POSITIONED IN AN IV POLE. A BIPOLAR OR MONOPOLAR FORCEPS WAS NOT USED WHILE THE SENSOR WAS PLUGGED IN. UNPLUGGING THE SENSOR FROM THE CERELINK CABLE (ID 826845) AND CABLE FROM THE MONITOR, THEN RECONNECTING DID NOT CLEAR THE ERROR (STILL NEGATIVE 50). ABOUT AN HOUR AFTERWARD, THE MONITOR BEGAN DISPLAYING POSITIVE MEANS FROM 15-25 WITH GOOD WAVEFORM. THE SENSOR WAS REMOVED ON (B)(6) 2022, DUE TO MONITORING NO LONGER NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2639647 CERELINK ICP PROBE BASIC KIT ICP MICRSOSENSORS - CERELINK GWM INTEGRA LIFESCIENCES SWITZERLAND SAR 826850 10381780520672

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown