BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAMINO MONITOR, UNKNOWN

    MDR report key: 6706202 · Received July 12, 2017

    Report

    Report Number
    2648988-2017-00021
    Event Type
    Malfunction
    Date Received
    July 12, 2017
    Report Date
    June 18, 2017
    Manufacturer
    INTEGRA LIFESCIENCES(IRELAND)
    Product Code
    GWM
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION : INITIAL MDR REPORTED ON 06/30/2017 UNDER INS8401 ACCUDRAIN. ON 27JUL2017, PRODUCT CLARIFICATION PROVIDED BY CUSTOMER, PRODUCT ID IS THE CAMINO, PROCODE: GWM; PRODUCT ID UNKNOWN. BASED ON ADDITIONAL INFORMATION THE FACILITY IDENTIFIER IS FEI#2023988, INTEGRA NEUROSCIENCES. (SD). INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON AUGUST 14, 2017. THE INVESTIGATION INCLUDED: METHODS: REVIEW OF DEVICE HISTORY RECORDS. REVIEW OF COMPLAINTS HISTORY. RESULTS: DHR REVIEW; THE SERIAL NUMBER OF THE CAM02 MONITOR WAS NOT PROVIDED FOR THIS COMPLAINT INCIDENT. THE CAM02 MONITOR SERIAL NUMBER IS REQUIRED TO COMPLETE A DHR REVIEW. THE DHR REVIEW WILL BE COMPLETED DURING THE FAILURE ANALYSIS IF THE SERIAL NUMBER BECOMES AVAILABLE. COMPLAINTS HISTORY; A REVIEW OF THE CUSTOMER COMPLAINTS WAS COMPETED USING THE FOLLOWING KEY WORDS ¿FALSE ICP¿ IN THE SEARCH CRITERIA. THE REVIEW ENCOMPASSED DATES 11-AUG16 TO 11-AUG-17. A TOTAL OF 164 COMPLAINTS WERE REVIEWED OF WHICH WAS A SINGLE COMPLAINT CONTAINED THE SEARCH CRITERIA. ADDITIONALLY, THE REVIEW VERIFIED THIS IS THE SINGLE COMPLAINT OCCURRENCE OF THE DEVICE UNDER INVESTIGATION. NO FURTHER ACTIONS ARE DEEMED NECESSARY. FUTURE INCIDENTS OF THIS NATURE WILL BE DOCUMENTED FOR RECURRENCE AND TRENDING PURPOSES. RATE OF OCCURRENCE: DURING THE TIME PERIOD ¿SEP 16 TO AUG 17¿, THE GLOBAL PRODUCT USAGE FOR CAM02 MONITORS WAS CALCULATED AS (B)(4) USAGES, USING THE TOTAL QUANTITY OF CAM02 MONITOR CATHETER SALES SOLD TO CALCULATE THE QUANTITY OF USAGES. 1 CATHETER IS USED PER PROCEDURE, AND IS USED AS A MEANS OF QUANTIFYING THE NUMBER OF PROCEDURES UNDERTAKEN. THE QUANTITY OF COMPLAINTS IN THE COMPLAINT REVIEW (1) CAN THEREFORE BE CALCULATED AS (B)(4) (REMOTE) OF PROCEDURES. THIS PERCENTAGE IS WITHIN THE EXPECTED RATE OF OCCURRENCE SCORED IN THE HEALTH RISK ASSESSMENT. CONCLUSION PRODUCT WAS NOT RETURNED SO THE EVALUATION WAS UNABLE TO BE PERFORMED. THEREFORE, AN INVESTIGATION FOR CAUSE WAS UNABLE TO BE PERFORMED. IF THE PRODUCT IS RETURNED FOR EVALUATION THE COMPLAINT WILL BE REOPENED AND THE EVALUATION WILL BE COMPLETED AND TRACKWISE UPDATED INCLUDING THE TRENDING REVIEW ACCORDINGLY PER COMPLAINT EVALUATION AND INVESTIGATION PROCEDURE.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE ACCUDRAIN WITH ANTI-REFLUX VALVE WAS GIVING A FALSE ICP. ADDITIONAL INFORMATION REQUEST WAS SENT AND 06JUL2017, THE FOLLOWING WAS PROVIDED BY THE CUSTOMER: THE PATIENT, A FEMALE IN HER 70'S WAS UNDERGOING PLACEMENT OF AN VENTRICULOSTOMER CATHETER. THE PRODUCT PROBLEM WAS DISCOVERED DURING POST INSERTION, OR AFTER THE INSERTION WHEN CONNECTING TO THE CAMINO MONITOR. "THE PATIENT HAD A "VENTRIC" CATHETER PLACED, THEN WHEN CONNECTED TO THE CAMINO MONITOR THERE WAS NOT A GOOD WAVEFORM AND THERE WAS A NEGATIVE ICP READING. WHEN CONNECTED TO THE ACCUDRAIN THE ICP WAVEFORM WAS GOOD AND THE ICP READING WAS GOOD" (REQUESTED CLARIFICATION FROM CUSTOMER REGARDING IF THERE WAS AN ISSUE WITH THE ACCUDRAIN OR A DIFFERENT PRODUCT BASED ON STATEMENT PROVIDED). THE PATIENT WAS SEDATED AND VENTED, THIS WAS DONE AT THE BEDSIDE. THERE WAS A REPLACEMENT PRODUCT AVAILABLE AND THERE WAS NO DELAY IN SURGERY. THERE WAS NO AWARENESS OF ANY PATIENT ADVERSE CONSEQUENCE OR PATIENT HARM OR INJURY. NO REVISION OR MEDICAL INTERVENTION REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    489190 CAMINO MONITOR, UNKNOWN N/A GWM INTEGRA LIFESCIENCES(IRELAND)

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR