BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERELINK ICP EXT CABLE

    MDR report key: 15146933 · Received August 2, 2022

    Report

    Report Number
    3013886523-2022-00357
    Event Type
    Malfunction
    Date Received
    August 2, 2022
    Date of Event
    July 13, 2022
    Report Date
    October 20, 2022
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    GWM
    PMA / PMN Number
    K210993
    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 CABLE WAS RETURNED FOR EVALUATION: DHR - THE LOT PROVIDED IS THE SUPPLIER LOT NUMBER, NOT INTEGRA. THE REVIEW OF THE HISTORY SUPPLIER LOT 19040804 SHOWED THAT THE POSSIBLE LOT USED IN THIS CASE IS WITHIN THE 4 FOLLOWING INTEGRA LOTS: 3646983, 3848591, 4042707 AND 4241924. ALL LOTS CONFORMED TO SPECIFICATIONS WHEN RELEASED TO STOCK. FAILURE ANALYSIS - THE CABLE WAS INSPECTED FOR CONNECTOR ALIGNMENT: NO DEFECT WAS NOTED. THE CABLE WAS ELECTRICALLY TESTED: NO ABNORMAL DISCONTINUITY AND NO ABNORMAL SHORT CIRCUIT WAS MEASURED. THE COMPLAINT EVALUATION WAS UNABLE TO CONCLUSIVELY VERIFY THE COMPLAINT AS VALID. DEVICE PASSED ALL TESTING. ISSUE IS NOT CONFIRMED AS DEVICE FUNCTIONED CORRECTLY AND PASSED ALL TESTING. THE ROOT CAUSE OF THE ISSUE REPORTED BY CUSTOMER COULD NOT BE DETERMINED AS THE DEVICE WORKED CORRECTLY. HOWEVER, THE POSSIBLE ROOT CAUSE OF THE DEFECT REPORTED BY THE CUSTOMER COULD BE DUE TO INAPPROPRIATE TECHNIQUE FOR ASSEMBLY AND USE OF THE DEVICE.

    Description of Event or Problem · 0

    2 OF 3 REPORTS (SAME PATIENT, SAME EVENT, DIFFERENT PRODUCTS) OTHER MFG REPORT NUMBERS: 3014334038-2022-00173, 3013886523-2022-00356. A FACILITY REPORTED: "THE SENSOR WAS ZEROED YESTERDAY AFTERNOON IN THE O.R. AND THEN THE PATIENT WAS BROUGHT TO THE ICU. THE PRESSURE WAS REALLY HIGH, ABOUT 40 MMHG. AFTER SOME HOURS OF CORRECT MEASURING, THE PRESSURE DECREASED UNTIL -50 MMHG AND THERE WAS THE ALARM ¿CHANGE CABLE OR SENSOR¿; THEY CHANGED 1CABLE BUT THE SITUATION WAS THE SAME, THEY CHANGED ALSO THE SENSOR, BUT IT WAS ALL USELESS. AT THAT POINT THEY CHANGED ALSO THE CERELINK MONITOR AND AFTER THAT THE MEASURING OF THE PIC STARTED CORRECTLY WITH ICP AT + 45 MMHG. THEY HAVE ALREADY RECEIVED THE SECURITY ADVISE BUT THEY DECIDED NOT TO SWITCH THE MONITOR CERELINK OFF FOR HALF AN HOUR BECAUSE IT WAS A VERY DELICATE CASE AND THEY HAD TO SEE THE ICP CONTINUOUSLY, WITHOUT INTERRUPTION." THE BATTERY WAS COMPLETELY CHARGED AND THEY TOOK OFF THE POWER ONLY IN THE OR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1944046 CERELINK ICP EXT CABLE CERELINK - CABLES GWM INTEGRA LIFESCIENCES MANSFIELD

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown