BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUBDURAL POST CRANIOTOMY ICP MONITORING KIT

    MDR report key: 4172275 · Received October 9, 2014

    Report

    Report Number
    2023988-2014-00050
    Event Type
    Malfunction
    Date Received
    October 9, 2014
    Report Date
    September 17, 2014
    Manufacturer
    INTEGRA NEURO SCIENCES CA/USA
    Product Code
    GWM
    PMA / PMN Number
    K102875
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON 11/0712014. REVIEW OF COMPLAINT HISTORY RESULTS: IT WAS REPORTED THAT THE DEVICE WAS DISCARDED. THE DESCRIPTIONS REPORTED LOT 305C00304377 AND 305C00304364. A REVIEW OF BATCH HISTORY RECORD LOT 305C00304377 AND 305C00304364 INDICATES THAT THEY MET REQUIREMENTS BEFORE RELEASED TO FG MFG DATE: MAY 13, 2014 AND EX DATE: APRIL 30, 2017. COMPLAINT HISTORY, MODEL 110-4XX, FROM OCTOBER 2013 THROUGH SEPTEMBER 2014 REVIEWED; THERE WERE 16 OTHER COMPLAINTS THAT ISSUED WITH COMPLAINT CODE PERF023, AND FOUR OF THEM WERE CONFIRMED. THE FAILURE RATE IS 0 01%. CONCLUSION: THE CUSTOMER'S COMPLAINT COULD NOT BE CONFIRMED. SINCE THE CUSTOMER DID NOT RETURNED THE PRODUCT FOR EVALUATION AND NO FURTHER INFORMATION ON THE DEVICE WAS PROVIDED, NO CONCLUSIONS COULD BE DRAWN, NOR ROOT CAUSE ESTABLISHED WITHOUT HAVING THE ACTUAL DEVICE TO EVALUATE AND ANALYZE. INTEGRA CONSIDERS THIS COMPLAINT CLOSED. FUTURE INCIDENTS OF THIS NATURE WILL BE DOCUMENTED FOR RECURRENCE AND TRENDING PURPOSES.

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION 06/09/2015. CONCLUSION: THE CUSTOMER'S COMPLAINT "ZERO ADJUSTMENT GOES WELL BUT THE SCREEN READS NO NUMBER WHEN CONNECTING WITH THE CATHETER AFTER PATIENT BACK TO WARD, EVEN CONNECTING TO ANOTHER MACHINE DID NOT WORK" COULD NOT BE CONFIRMED. THE RETURNED DEVICE WAS FUNCTIONALLY TESTED AND MET SPECIFICATIONS. IT WAS NOTED THAT THE CATHETER HAD A MINOR SHIFT IN READINGS BETWEEN THE FIRST AND SECOND TIME THE CATHETER WAS CONNECTED TO THE TEST MONITOR, HOWEVER THIS DISCREPANCY WOULD NOT RESULT IN THE CUSTOMERS DESCRIPTION OF THE COMPLAINT OF "SCREEN READS NO NUMBER." A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO ANOMALIES DURING THE MANUFACTURING, INSPECTION AND PACKAGING OF THE DEVICE, THE CATHETER MET SPECS. A REVIEW OF THE HAZARD (DOES NOT MEASURE INTRACRANIAL TEMPERATURE ACCURATELY) ANALYSIS FOUND THE HARM AS A DELAY IN TREATMENT, THIS RISK WAS DETERMINED TO BE ACCEPTABLE BASED ON THE LIKELIHOOD THE HAZARD RESULTS IN SEVENTY OF HARM IS MODERATE.

    Additional Manufacturer Narrative · 1

    THE DEVICES INVOLVED IN THE REPORTED INCIDENT ARE NOT EXPECTED TO BE RECEIVED FOR EVALUATION. THE PRODUCTS HAVE BEEN DISCARDED BY THE CUSTOMER. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE ZERO ADJUSTMENT GOES WELL BUT THE SCREEN DOES NOT READ ANY NUMBER WHEN CONNECTING THE CATHETER AFTER PATIENT RETURNED BACK TO THE PATIENT WARD. THE CATHETER DID NOT WORK EVEN AFTER CONNECTING TO ANOTHER MACHINE. IT WAS REPORTED IT OCCURRED TO 3 CATHETERS. REQUEST FOR CLARIFICATION AND ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT TO DATE, NO RESPONSE HAS BEEN RECEIVED FROM THE DISTRIBUTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636904 SUBDURAL POST CRANIOTOMY ICP MONITORING KIT NA GWM INTEGRA NEURO SCIENCES CA/USA 110-4XX 305C00304377 AND 305C00304364

    Patients

    Seq Age Sex Outcome Treatment
    1