BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OLM INTRACRANIAL PRESSURE MONITORING KIT

    MDR report key: 5211971 · Received November 9, 2015

    Report

    Report Number
    2023988-2015-00045
    Event Type
    Injury
    Date Received
    November 9, 2015
    Date of Event
    September 25, 2015
    Report Date
    September 25, 2015
    Manufacturer
    INTEGRA NEUROSCIENCES CA/USA
    Product Code
    GWM
    PMA / PMN Number
    K102875
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    METHODS: REVIEW OF DEVICE HISTORY RECORDS. REVIEW OF COMPLAINTS HISTORY. RESULTS: THE CUSTOMER RETURNED ONLY THE INNER BOX, LOT 3050RX322850, THAT DOES NOT HAVE THE CATHETER OR COMPONENTS. TESTING COULD NOT BE PERFORMED. A REVIEW OF LOT 3050RX322850 INDICATES THAT IT MET REQUIREMENTS BEFORE RELEASED TO FINISHED GOODS. LOT WAS MFG ON 30-APR-2015 AND WILL BE EXPIRED ON 31-DEC-2017 COMPLAINT HISTORY, MODEL 110-4XXX, FROM OCT-2014 THROUGH SEP-2015 REVIEWED; THERE WERE NINE OTHER COMPLAINTS THAT ISSUED WITH COMPLAINT CODE (B)(4), AND FOUR OF THEM WERE CONFIRMED THEREFORE THE CURRENT COMPLAINT RATE IS (B)(4). CONCLUSION: A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY ANOMALIES OBSERVED DURING THE MANUFACTURING, PACKAGING OR INSPECTION OF THE DEVICE OR ACCESSORIES WHILE IN PROCESS. ADDITIONAL INFORMATION RECEIVED FROM THE COMPLAINANT DOES NOT ALLOW FOR CONFIRMATION NOR DENIAL OF REASONABLY FORESEEABLE MISUSE OF THE CATHETER OR ACCESSORIES. ADDITIONALLY, BECAUSE THE PRODUCT WAS NOT RETURNED FOR EVALUATION, NO ROOT CAUSE ESTABLISHED FOR THE FAILURE MODE DESCRIBED IN THE CUSTOMER COMPLAINT.

    Description of Event or Problem · 1

    THIS IS THE FIRST OF TWO REPORTS. THIS IS IN REGARDS TO THE FIRST CATHETER. POOR CONNECTION TO THE CAMINO MONITOR WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED AND ON 16OCT2015 THE FOLLOWING WAS PROVIDED BY THE CUSTOMER: A (B)(6) MALE PATIENT HAD INJURIES: MOTORCYCLE VERSUS SEMI- SCATTERED SUBARACHNOID HEMORRHAGE (SAH), SHEARING. WHEN TRYING TO ZERO THE CATHETER TO ATMOSPHERE WHILE THE BOLT WAS OUT OF THE PATIENT'S HEAD, THE CAMINO READ "NO CATHETER CONNECTION". THE CATHETER WAS CHANGED OUT. THE PHYSICIAN WAS ABLE TO ZERO THE CATHETER. THE BOLT WAS INSERTED INTO THE PATIENT. THE INTRACRANIAL PRESSURE (ICP) READ 30'S. IT WAS UNKNOWN IF THE DURA MATER WAS OPENED PER INSTRUCTIONS FOR USE (IFU) PRIOR TO BOLT/CATHETER INSERTION. THE CATHETER WAS PULLED BACK SLIGHTLY AFTER INSERTION. THE CATHETER WAS DRESSED WITH 2 TEGADERMS AND THE CABLE WAS SECURED WITH THE CLIP. ONE HOUR LATER, THE BOLT WAS READING -39. THREE OTHER CAMINO MONITORS WERE USED AND IT ALL READ -39. THE PHYSICIAN RETURNED 3 HOURS LATER, SWITCHED THE ZEROING CABLES (BLACK BOX CONNECTION) WITH NO IMPROVEMENT. THE PHYSICIAN THEN RE-THREADED A BOLT FROM THE OPERATING ROOM (OR) STOCK AND THE ICP HAD A NICE WAVEFORM AND READ 10. THERE WAS NO PATIENT INJURY. THERE WAS A DELAY IN INTRACRANIAL PRESSURE (ICP) READINGS. THERE WAS NO PATIENT CONSEQUENCES AS A RESULT OF THE DELAY. REQUEST FOR ADDITIONAL CLARIFICATION WAS SENT TO THE CUSTOMER (VERIFICATION OF HOW MANY CATHETERS WERE USED ON THE PATIENT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    743144 OLM INTRACRANIAL PRESSURE MONITORING KIT N/A GWM INTEGRA NEUROSCIENCES CA/USA 30500X324867

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention