BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECIAL EVD 10-110 W/O Y SITE

    MDR report key: 6083010 · Received November 7, 2016

    Report

    Report Number
    2648988-2016-00049
    Event Type
    Malfunction
    Date Received
    November 7, 2016
    Report Date
    October 12, 2016
    Manufacturer
    INTEGRA NEUROSCIENCES PR
    Product Code
    JXG
    PMA / PMN Number
    K042825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION COMPLETED 5/10/2017. METHOD: -DEVICE HISTORY REVIEW, -TREND ANALYSIS. LOT NUMBERS WERE OBTAINED FROM THE LABELS OF THE RETURNED DEVICES. THESE WERE NOT REPORTED IN THE COMPLAINT INFORMATION ORIGINALLY PROVIDED. THUS, DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED AS PART OF THE FAILURE ANALYSIS EVALUATION AS FOLLOWS: LOT NUMBER: 1151963, CATALOG NUMBER: SP0090, MANUFACTURING DATE: JUNE 04, 2015, EXPIRATION DATE: MAY - 2017. LOT NUMBER: 1162632, CATALOG NUMBER: SP0090, (B)(4), MANUFACTURING DATE: JULY 08, 2016, EXPIRATION DATE: JUNE 30, 2018. LOT NUMBER: 1163040, CATALOG NUMBER: SP0090, (B)(4), MANUFACTURING DATE: JULY 18, 2016, EXPIRATION DATE: JUNE 30, 2018. LOT NUMBER: 1164080, CATALOG NUMBER: SP0090, (B)(4), MANUFACTURING DATE: NOVEMBER 09, 2016, EXPIRATION DATE: OCTOBER 31, 2018. NOTHING UNUSUAL WAS NOTICED IN THE DHR REVIEW THAT COULD HAVE CAUSED THE REPORTED EVENT. ADDITIONAL INFORMATION: THE IFU INSTRUCTS TO VERIFY THAT ALL CONNECTIONS ARE SECURELY ATTACHED AND LEAK FREE. THE IFU MAKES THE FOLLOWING STATEMENTS: ¿PREPARATION: THE SYSTEM SHOULD BE PREPARED UNDER STERILE CONDITIONS PRIOR TO THE PLACEMENT OF THE VENTRICULAR OR LUMBAR CATHETER. ENSURE THAT ALL COMPONENTS ARE SECURELY ATTACHED. THE SYSTEM SHOULD BE FILLED WITH STERILE NORMAL SALINE PRIOR TO CONNECTING TO THE PATIENT. INJECTION SITES AND END CAPS MAY BE TEMPORARILY LOOSENED TO ALLOW AIR TO ESCAPE. CHECK TO ENSURE THAT ALL CONNECTIONS ARE SECURE AND LEAK-FREE.¿ ¿TO MONITOR PRESSURE FOLLOW THE TRANSDUCER MANUFACTURER'S INSTRUCTIONS FOR TRANSDUCER SET-UP AND CALIBRATION.¿ ¿SYSTEM CALIBRATION: INITIAL SYSTEM CALIBRATION SHOULD BE COMPLETED PRIOR TO CONNECTING TO THE PATIENT. INSTRUCTIONS FROM THE TRANSDUCER MANUFACTURER SHOULD BE FOLLOWED FOR TRANSDUCER CALIBRATION.¿ ¿PRECAUTIONS: ALL LUER CONNECTIONS MUST BE CHECKED DURING THE PREPARATION OF THE SYSTEM AND PRIOR TO CONNECTING TO THE PATIENT. ENSURE THAT ALL CONNECTIONS ARE SECURE AND LEAK-FREE.¿ UPON REVIEW OF INTEGRA'S COMPLAINT SYSTEM FROM OCTOBER 2014 TO OCTOBER 2016, THERE ARE THREE (3) COMPLAINTS (INCLUDING THIS ONE) RELATED TO ¿TRANSDUCER DISCONNECTION¿ FOR THE FOR EXTERNAL DRAINAGE (MONITORR) PRODUCT FAMILY. AT THE MOMENT ALL OF THE COMPLAINTS ARE FROM THE SAME FACILITY. A DEVICE AND A TRANSDUCER WERE RETURNED AND THE COMPLAINT COULD NOT BE DUPLICATED, THUS IT WAS NOT CONFIRMED. MONITORR¿S CONNECTING STOPCOCK WAS IN GOOD STATE, NO DEFECT WAS DETECTED. NO OTHER DEVICE HAS BEEN RETURNED FOR EVALUATION. SO FAR NO DEFECTS HAVE BEEN DETECTED ON THE MONITORR EVD DEVICE THAT COULD CAUSE THE DISCONNECTION EVENTS. THE SITUATION MAY BE RELATED TO THE TRANSDUCER USED OR USER RELATED. (B)(4). EACH MONITORR UNIT WAS RECEIVED WITH A TRANSDUCER OF AN UNKNOWN MANUFACTURER. THE UNIT WAS VISUALLY INSPECTED AND WAS FOUND TO BE IN GOOD CONDITION. THE MANIFOLD STOPCOCK WAS VERIFIED AND PHOTOGRAPHED: ALL WERE FOUND IN PERFECT CONDITION. NO DEFECTS WERE DETECTED DURING THE PRODUCT INSPECTION. THE MONITORR STOPCOCK HAS NO MOVING PARTS. STOPCOCKS USED ARE STANDARD OFF THE SHELF PRODUCTS. THE STOPCOCK¿S LUER THREADS WERE VERIFIED AND NO DEFECT WAS DETECTED. THE NON-INTEGRA TRANSDUCER IS ATTACHED TO THE MONITORR¿S FEMALE LUER PART OF THE STOPCOCK AND IS HELD IN PLACE BY MEANS OF THE TRANSDUCER¿ LUER NUT. THE TRANSDUCER WAS VISUALLY INSPECTED. NO CRACKS WERE NOTICED ON THE LUER NUT AND THREADS SEEMED IN GOOD CONDITION. THE ONLY MOVING PART IN THE TRANSDUCER/ STOPCOCK FIXTURE BELONGS TO THE TRANSDUCER (THE LUER NUT). FOR EACH RETURNED UNIT, THE NON-INTEGRA TRANSDUCER WAS ATTACHED TO THE STOPCOCK. A GOOD HOLD WAS OBTAINED BETWEEN THE TWO (2) COMPONENTS. THE COMPONENTS WERE PULLED OUTWARD, UP AND DOWN, AND SIDEWAYS. THE CONNECTION WAS TIGHT AND DID NOT BREAK APART; NONETHELESS, IT WAS EVIDENCED THAT EVENTUALLY WITH MOVEMENT THE TRANSDUCER¿S LUER NUT WOULD LOOSEN-UP. ALSO, IF THE TRANSDUCER IS ROTATED, THE LUER NUT TURNS WITH IT AND LOSES ITS HOLD/GRIP. NO DEFECT WAS NOTICED ON THE STOPCOCK OF THE MONITORR DEVICE AND INITIALLY A STRONG HOLD WAS OBTAINED BETWEEN THE TWO COMPONENTS (MONITORR/TRANSDUCER) WHEN ASSEMBLED TOGETHER. THE COMPLAINT IS CONSIDERED NOT CONFIRMED SINCE THE CONDITION WHERE THE TRANSDUCER WOULD FALL OFF WITHOUT EXTERNAL INTERVENTION COULD NOT BE REPRODUCED AND THE ONLY WAY EVIDENCED FOR THE TWO COMPONENTS TO SEPARATE WOULD BE AS THE RESULT OF CONTINUOUS OR REPETITIVE HANDLING. CONCLUSION: NO MANUFACTURING DEFECTS OR UNUSUAL EVENTS WERE DETECTED FROM LOT DOCUMENT REVIEW OR RETURNED SAMPLE EVALUATION. THE FOLLOWING WAS OBSERVED: IF BOTH COMPONENTS ARE TIGHTLY FASTENED, THERE IS A GOOD HOLD AND IT IS VERY UNLIKELY THAT A SPONTANEOUS DISCONNECTION (WITHOUT AN EXTERNAL CAUSE) WILL HAPPEN. POSSIBLE ROOT CAUSES FOR THIS EVENT ARE: NON-INTEGRA¿S TRANSDUCER (NOT COMPATIBLE OR DEFECTIVE), UNDER-TIGHTENING. LOOSENING OF THE TRANSDUCER¿S LUER NUT CONNECTION DUE TO HANDLING. NO DEFECTS WERE FOUND ON THE EXTERNAL DRAINAGE SYSTEM, MONITORR. THE STOPCOCKS USED ARE WHAT IS KNOWN AS AN OFF THE SHELF COMPONENT (NOT SPECIALLY DESIGNED FOR INTEGRA). VISUAL INSPECTION OF THE STOPCOCKS CONFIRMED THAT THESE WERE IN GOOD CONDITIONS AND THEREFORE NOT SUSPECTED TO BE THE CAUSE OF THE FAILURE. FAILURE ANALYSIS USING HOSPITAL¿S TRANSDUCER (NOT INTEGRA¿S) DEMONSTRATED THAT THE TRANSDUCER¿S LUER NUT LOOSENED-UP AS RESULT OF HANDLING AND MOST LIKELY MULTIPLE TIMES. THEREFORE, IT MAY APPEAR TO THE USER THAT NOTHING WAS BEING DONE AT THE MOMENT WHEN THE TRANSDUCER FINALLY DISCONNECTED (AS IT WAS MOST LIKELY ALREADY LOOSE). IN CONCLUSION: THE CONDITION WHERE THE TRANSDUCER WOULD FALL OFF WITHOUT EXTERNAL INTERVENTION COULD NOT BE REPRODUCED; NO DEFECT WAS FOUND ON THE STOPCOCK OF THE MONITORR; NO EVIDENCE WAS FOUND THAT THE DEVICE IS THE CAUSE OF THE REPORTED EVENT; THE ROOT CAUSE IS CONSIDERED UNDETERMINED (ALTHOUGH IT COULD BE RELATED TO THE TRANSDUCER OR HANDLING).

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON 12/01/2016. THE PRODUCT WAS NOT RETURNED FOR EVALUATION. DHR REVIEW WAS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. UPON REVIEW OF INTEGRA'S COMPLAINT SYSTEM FROM OCTOBER 2014 TO OCTOBER 2016, THERE ARE THREE (3) COMPLAINTS (INCLUDING THIS ONE) RELATED TO ¿TRANSDUCER DISCONNECTION¿ FOR THE FOR EXTERNAL DRAINAGE (MONITOR) PRODUCT FAMILY. APPROXIMATELY (B)(4) UNITS WERE RELEASED FOR DISTRIBUTION FROM OCTOBER 2014 TO OCTOBER 2016. THEREFORE, THE COMPLAINT OCCURRENCE RATE FOR THIS TYPE OF INCIDENT IS (B)(4). CONCLUSION: REVIEW OF IFU STATEMENTS AS FOLLOWS: -¿PREPARATION THE SYSTEM SHOULD BE PREPARED UNDER STERILE CONDITIONS PRIOR TO THE PLACEMENT OF THE VENTRICULAR OR LUMBAR CATHETER. ENSURE THAT ALL COMPONENTS ARE SECURELY ATTACHED AS ILLUSTRATED IN FIGURE 2 (OF IFU). THE SYSTEM SHOULD BE FILLED WITH STERILE NORMAL SALINE PRIOR TO CONNECTING TO THE PATIENT. INJECTION SITES AND END CAPS MAY BE TEMPORARILY LOOSENED TO ALLOW AIR TO ESCAPE. CHECK TO ENSURE THAT ALL CONNECTIONS ARE SECURE AND LEAK-FREE.¿ -¿TO MONITOR PRESSURE FOLLOW THE TRANSDUCER MANUFACTURER'S INSTRUCTIONS FOR TRANSDUCER SET-UP AND CALIBRATION.¿ ¿SYSTEM CALIBRATION INITIAL SYSTEM CALIBRATION SHOULD BE COMPLETED PRIOR TO CONNECTING TO THE PATIENT. INSTRUCTIONS FROM THE TRANSDUCER MANUFACTURER SHOULD BE FOLLOWED FOR TRANSDUCER CALIBRATION.¿ -¿PRECAUTIONS ALL LUER CONNECTIONS MUST BE CHECKED DURING THE PREPARATION OF THE SYSTEM AND PRIOR TO CONNECTING TO THE PATIENT. ENSURE THAT ALL CONNECTIONS ARE SECURE AND LEAK-FREE.¿ NO DEFECTS HAVE BEEN DETECTED ON THE MONITOR EVD PRODUCT THAT COULD CAUSE THE DISCONNECTION EVENTS. THE SITUATION MAY BE RELATED TO THE TRANSDUCER USED OR USER RELATED. THE CLIENT HASN¿T DISCLOSED INFORMATION REGARDING THE PROCEDURE USED TO ATTACH THE TRANSDUCERS (SET-UP), OR IF THE EVENTS ARE ISOLATED TO CERTAIN USERS ONLY. THE CLIENT INFORMED OUR CLINICAL SALES/ CLINICAL EDUCATION SPECIALIST THAT THEY ARE EVALUATING OTHER TRANSDUCERS TO USE WITH PRODUCT. LOT AND CATALOG NUMBERS FOR THE DEVICE INVOLVED IN THIS EVENT ARE UNKNOWN. NO DEVICE HAS BEEN RETURNED FOR EVALUATION AND IT IS UNCERTAIN IF THE DEVICE WILL BE RETURNED. FURTHER INVESTIGATION IS NOT POSSIBLE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE ACCUDRAIN HAD A DISCONNECTION. THE INCIDENT OF THE TRANSDUCER COMING OFF OCCURRED WHILE MOVING THE PATIENT TO A STRETCHER. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    735473 SPECIAL EVD 10-110 W/O Y SITE N/A JXG INTEGRA NEUROSCIENCES PR 1151963

    Patients

    Seq Age Sex Outcome Treatment
    1