BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERELINK ICP PROBE 1L M BOLT

    MDR report key: 21230314 · Received January 24, 2025

    Report

    Report Number
    3013886523-2025-00014
    Event Type
    Malfunction
    Date Received
    January 24, 2025
    Date of Event
    December 26, 2024
    Report Date
    March 28, 2025
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    GWM
    UDI-DI
    10381780520689
    PMA / PMN Number
    K173192
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: D4, D9, G3, G6, H2, H3, H6, H11. THE CERELINK SENSOR (ID 826851) WAS NOT RETURNED FOR EVALUATION AFTER THREE GOOD FAITH ATTEMPTS (GFES) WERE MADE. LOT NUMBER INFORMATION HAS NOT BEEN PROVIDED; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED, AND DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED. THE ROOT CAUSE(S) OF THE REPORTED ISSUE COULD NOT BE DETERMINED. HOWEVER, A PROBABLE ROOT CAUSE FOR THE REPORTED COMPLAINT IS DUE TO MEMORY DOES NOT WITHSTAND SUFFICIENT WRITE CYCLES. 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.

    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.

    Description of Event or Problem · 0

    2 OF 2 REPORTS. OTHER MFG REPORT NUMBER: 3013886523-2025-00013. A FACILITY REPORTED: "THE NURSE AND SURGEON WERE UNABLE TO ZERO THE MICROSENSOR. IN A SEVERE TBI (TRAUMATIC BRAIN INJURY) PATIENT, A BASIC MICROSENSOR WAS TO BE PLACED INTRA-OP POST CRANIOTOMY. THE SURGEON AND THE OR NURSE STATED THEY COULDN¿T GET THE MICROSENSOR TO ZERO. INCIDENT: THE ICP EXTENSION CABLE FROM THE CERELINK MONITOR WAS ATTACHED TO THE BASIC MICROSENSOR. THE NURSE PRESSED THE ¿ZERO SENSOR¿ BUTTON. THE SURGEON PLACED THE TIP OF THE MICROSENSOR INTO A SHALLOW POOL OF NS AND THE NURSE PRESSED THE -0- BUTTON. A RED LINE APPEARED, AND SENOR WOULD NOT ZERO. SALES REPRESENTATIVE LET THE SURGEON KNOW TO BE SURE TO KEEP THE SENSOR STILL AND HE INSISTED IT WAS. HE TRIED SEVERAL TIMES TO ZERO THE SENSOR, BUT WITHOUT SUCCESS. SO, HE OPENED A METAL SKULL BOLT KIT, AND THE EXACT SAME THING OCCURRED. HE DENIED ANY PRESSURE AGAINST THE MICROSENSOR SENSOR TIP (ON THE TRANSDUCER) AND INSISTED THAT HE WAS STEADY AND STILL (NOT MOVING) WHILE IN THE NORMAL SALINE DURING THE ZEROING OF THE TRANSDUCER. THIS FACILITY ONLY OWNS ONE CERELINK MONITOR, SO THEY WERE UNABLE TRY ANOTHER MONITOR. THE SURGEON STATED THAT HE CANNOT PLACE AN EVD TO MONITOR ICP DUE TO THE PTS MASSIVE CEREBRAL EDEMA. BECAUSE OF THE INABILITY TO MONITOR ICP IN THIS EXTREMELY CRITICAL PATIENT, HE DECIDED TO PLACE THE PATIENT IN A PENTOBARB COMA AND TRANSFER THEM TO BLAKE MEDICAL CENTER." NO PATIENT INJURY, NO SURGICAL DELAY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    859299 CERELINK ICP PROBE 1L M BOLT ICP MICRSOSENSORS - CERELINK GWM INTEGRA LIFESCIENCES MANSFIELD 10381780520689

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown