BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRA CAMINO ICP MONITOR

    MDR report key: 7638161 · Received June 26, 2018

    Report

    Report Number
    2023988-2018-00037
    Event Type
    Malfunction
    Date Received
    June 26, 2018
    Date of Event
    June 4, 2018
    Report Date
    June 26, 2018
    Manufacturer
    INTEGRA LIFESCIENCES (IRELAND) LIMITED
    Product Code
    GWM
    UDI-DI
    10381780039310
    PMA / PMN Number
    K121573
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: SECTION G1-CONTACT OFFICE: (B)(6). ADDITIONAL INFORMATION RECEIVED 07JUNE2018: NO DELAY IN SURGERY AS THE PROCEDURE WAS DONE AT BEDSIDE. THE ISSUE IS THAT THE MONITOR WAS NOT READING THE CATHETER. NATUS COMPLETED THEIR INVESTIGATION ON 04SEPTEMBER2018. INVESTIGATION RESULTS INCLUDED THE FOLLOWING: METHODS: EVALUATION OF ACTUAL DEVICE. REVIEW OF DEVICE HISTORY RECORD. REVIEW OF PAST CAPAS/CAPA DETERMINATION. REVIEW OF RISK MANAGEMENT. THE CUSTOMER'S COMPLAINT "110 4 B OLM PARENCHYMAL CATHETER CONNECTED TO CAMINO MONITOR SERIAL NUMBER 1171004247, STATUS BAR INITIALLY READ "CATHETER IS INITIALIZING", THEN CHANGED TO "CATHETER FAILURE"." WAS CONFIRMED. FAULT TRACED TO CAMCABL- THE MONITOR OPERATED CORRECTLY WITH NO ISSUES. DEVICE HISTORY RECORD REVIEW: THE DHR FOR THE MONITOR WAS REVIEWED AND NO ANOMALIES THAT COULD BE ASSOCIATED WITH THE COMPLAINT INCIDENT WERE OBSERVED. CAPA: A REVIEW OF CAPAS INITIATED WITHIN THE PAST 24MONTHS, OPEN CAPA AND CLOSED SPECIFICALLY RELATED TO THE COMPLAINT WAS COMPLETED TO DETERMINE IF A SIMILAR COMPLAINT IS EITHER UNDER ACTIVE CAPA INVESTIGATION OR HAVE BEEN PREVIOUSLY ADDRESSED THROUGH A CAPA THE REVIEW FOUND NONE OF THE CAPA'S SCOPE WERE CONSIDERED RELATED TO THIS COMPLAINT INCIDENT. COMPLAINT HISTORY REVIEW/ TREND ANALYSIS: BASED ON THE COMPLAINT DESCRIPTION A REVIEW OF THE COMPLAINTS WAS PERFORMED USING THE FOLLOWING KEY WORDS "INTEG-LMPROPER FUNCTION" IN THE SEARCH CRITERIA. THE REVIEW ENCOMPASSED JUL-2016 THROUGH JUN-2018. THERE WERE 56 OTHER COMPLAINTS THAT WERE REPORTED AND 21 WERE CONFIRMED. THE NUMBER OF CONFIRMED REPORTS 21 DIVIDED BY THE NUMBER OF UNITS SOLD 1080, FROM JUN-2016 THROUGH JUN-2018 AND MULTIPLIED BY 100 RESULTS IN A FAILURE RATE PERCENTAGE 1.944%. RISK MANAGEMENT REVIEW: THE CAM02 MEDICAL DEVICE HAZARD ANALYSIS (TABLE B) REV. 1, IDENTIFIES THE COMPLAINT AS "MONITOR NOT FUNCTIONAL PRIOR TO USE". RESULTING IN A HAZARDOUS SITUATION OF "DAMAGE TO MONITOR OR TO INTERFACE CABLE"" (DIA007), WITH A HARM OF "INCONVENIENCE TO USER" AND SEVERITY OF "NEGLIGIBLE". ROOT CAUSE: FAULT TRACED TO CAMCABL WAS REPLACED. THIS COMPLAINT IS NOW DEEMED CLOSED.

    Description of Event or Problem · 1

    THE 110 4 B OLM PARENCHYMAL CATHETER CONNECTED TO CAMINO MONITOR SERIAL NUMBER (B)(4), STATUS BAR INITIALLY READ "CATHETER IS INITIALIZING", THEN CHANGED TO "CATHETER FAILURE". SURGEON REPLACE INITIAL 110 4 B CATHETER WITH ANOTHER 110 4 B CATHETER, AND RECEIVED THE SAME READINGS - INITIALLY READ "CATHETER IS INITIALIZING", THEN CHANGED TO "CATHETER FAILURE". CAMINO MONITOR SERIAL NUMBER (B)(4) WAS SWITCHED OUT WITH DIFFERENT MONITOR, WITH SECOND CATHETER, AND RECEIVED NO ERROR MESSAGES. CATHETER PERFORMED NORMALLY AFTER SWITCHING OUT MONITOR. NO ALLEGED DEATH/ INJURY. PATIENT INFORMATION: NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480624 INTEGRA CAMINO ICP MONITOR INTRACRANIAL PRESSURE MONITORING DEVICE GWM INTEGRA LIFESCIENCES (IRELAND) LIMITED CAM02 10381780039310

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention