NT821731C, EDS 3, GEN LL, NO CATHETER
Report
- Report Number
- 2023988-2023-00029
- Event Type
- Malfunction
- Date Received
- September 13, 2023
- Date of Event
- September 6, 2023
- Report Date
- November 9, 2023
- Manufacturer
- NATUS MEDICAL INCORPORATED
- Product Code
- JXG
- PMA / PMN Number
- K162437
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
INITIAL REPORT REF TO NATUS COMPLAINT # (B)(4). FURTHER INVESTIGATION TO BE CARRIED OUT.
INITIAL REPORT REF TO NATUS COMPLAINT #(B)(4). (RELATED TO MDR REPORT# MW5146018, MW5146019) AND (MDR 2023988-2023-00028 NATUS COMPLAINT #(B)(4)). STERILE DATE OF AFFECTED PRODUCT: (B)(6) 2023. THE DEVICE HISTORY RECORD WAS REVIEWED, THE RAW MATERIALS USED IN THE MANUFACTURING MET SPECIFICATIONS AND THERE WERE NO ANOMALIES OBSERVED DURING THE MANUFACTURING, PACKAGING, OR INSPECTION OF THE DEVICE IN PROCESS. THE PRODUCT WAS STERILIZED UNDER STERILE LOAD C230602, STERILITY AND PYROGEN TEST MET REQUIREMENTS. A REVIEW OF CAPA'S INITIATED WITHIN THE PAST 12 MONTHS, WERE REVIEWED TO DETERMINE IF ANY CAPAS WERE GENERATED SPECIFICALLY RELATED TO THE CUSTOMER'S COMPLAINT. THE REVIEW FOUND ZERO (0) CAPAS WHERE THE SCOPE IS RELATED TO THIS COMPLAINT INCIDENT. COMPLAINT HISTORY REVIEW/TREND ANALYSIS: (24 MONTHS REVIEW AND PERCENT OF SALES) 0 PREVIOUSLY CONFIRMED "LNTEG-LMPROPER FUNCTION" COMPLAINTS WITHIN THE PAST TWO YEARS. (B)(4) NT821731 C, 30C AND 38C (THE THREE SK US CONTAIN THE DRAINAGE SYSTEM) UNITS SOLD WITHIN PAST TWO YEARS. FAILURE RATE = (B)(4). A REVIEW OF DOC-035405 REV 06 RISK ANALYSIS SPREADSHEET-EDS3 EXTERNAL DRAINAGE SYSTEM (REV 06), IDENTIFIES THE HAZARD SITUATION AS "2.2 CEREBROSPINAL FLUID (CSF) WITH LEACHABLE FLOWS BACK TO THE PATIENT VENTRICULAR/LUMBAR" BASED ON COMPLAINT OF "CSF BACK FLOW." THE RESIDUAL RISK LEVEL IS ACCEPTABLE, THE RISK-BENEFIT RATIONAL IS LOW RISK OUTWEIGHED BY THE USE OF THE DEVICE. THIS DETERMINATION IS BASED ON THE INFORMATION RECEIVED FROM THE CUSTOMER. ROOT CAUSE/FAILURE INVESTIGATION: IN SUMMARY, THE THREE LIKELY CAUSES OF THIS BACKFLOW OF AIR ARE THE POSITION OF THE DRIP CHAMBER, CHANGE IN THE PATIENT POSITION AND THE NEGATIVE ICP. THE FIRST SCENARIO OF THE POSITION OF THE DRIP CHAMBER IS PLACED AT A HIGHER PRESSURE THAN THE ICP, WHICH CREATES THE BACK PRESSURE, AND THE CSF IN THE SYSTEM TUBING TRIES TO FLOW BACK UNTIL THE PRESSURE IN THE TUBING EQUILIBRIUM TO THE GRADUATED CYLINDER (ICP). DURING THE TEST, BY PLACING THE BURETTE IN AN ELEVATED POSITION, WHICH MEANS AT A HIGHER PRESSURE THAN THE PRESSURE IN THE GRADUATED CYLINDER (ICP), THE BACKFLOW OF FLUID WAS OBSERVED. THE ICP RESISTS THE BACKFLOW AT AN ACCEPTABLE LEVEL OF SET PRESSURE IN THE DRIP CHAMBER; ONCE THE SET LEVEL OF THE DRIP CHAMBER IS HIGHER THAN THE THRESHOLD, THE CSF FLOWS BACK INTO THE PATIENT. BY PLACING THE BURETTE HIGHER THAN THE THRESHOLD, THE CSF DRAINS DOWNSTREAM UNTIL IT IS RESISTED. IN THE SECOND SCENARIO OF A CHANGE IN THE POSITION OF THE PATIENT, WHEN THE POSITION OF THE PATIENT WAS LOWERED WITHOUT CLAMPING THE TUBING OR CHANGING THE DRIP CHAMBER POSITION RELATIVE TO THE PATIENT'S HEAD OR BED POSITION, IT CREATED A PRESSURE DIFFERENCE BETWEEN THE DRIP CHAMBER AND THE ICP. IF THE PATIENT'S POSITION IS RAISED, THEN THEY ARE ESSENTIALLY DROPPING THE DRAINAGE SYSTEM OR DRIP CHAMBER, WHICH MEANS THERE WILL BE A MUCH LOWER THRESHOLD FOR DRAINAGE, WHICH MEANS THE PATIENT COULD DUMP CSF, WHICH IS DANGEROUS. IF THE PATIENT POSITION IS LOWERED DOWN, THEN ESSENTIALLY RAISING/ ELEVATING THE DRAINAGE SYSTEM/DRIP CHAMBER MEANS THERE WILL BE BACK PRESSURE, AND THAT CREATES THE BACKFLOW. THE ICP RESISTS THE BACKFLOW AT AN ACCEPTABLE LEVEL OF SET PRESSURE IN THE DRIP CHAMBER. THIS SCENARIO WAS RECREATED DURING THE TESTING. WHEN THE DRIP CHAMBER IS SET AT 5 MMHG AND THE GRADUATED CYLINDER IS LOWERED TO A PRESSURE AT 1 MMHG, A BACKFLOW IS OBSERVED. IN THE THIRD SCENARIO, NEGATIVE ICP, THIS PHENOMENON CAN CAUSE DUE TO PATIENT CONDITION, IN THIS CASE, THE PATIENT REPORTED WITH VENTRICULITIS. AS PER COMPLIANT, THERE WAS NO ISSUES WITH THE FIRST NATUS DRAIN, WHEN THE PATIENT HAS VENTRICULITIS, USER DECIDED TO CHANGE THE EVD CATHETER WITH A NEW NATUS DRAINAGE SYSTEM, THEN THEY ENCOUNTERED THE BACK FLOW ISSUE. WHEN THE SYSTEM IS LEVELED TO THE PATIENT'S DESIRED ICP, IF THERE IS A DROP IN THE ICP (NEGATIVE) AND THE DRIP CHAMBER IS STILL IN THE SAME POSITION, THEN THERE IS A PRESSURE DIFFERENCE BETWEEN THE ICP AND THE DRIP CHAMBER. IN THIS SITUATION, THE CSF IN THE TUBING TRIES TO FLOW BACK BECAUSE THE NEGATIVE ICP CREATES THE BACK PRESSURE. THIS SCENARIO WAS RECREATED DURING THE TESTING. REVIEW OF THE DOC-035405 REV 06 NATUS EDS 3 EXTERNAL DRAINAGE SYSTEM - RISK ANALYSIS SPREADSHEET (RAS), LINE ITEM 18, HAZARD ID 2.2 IDENTIFIES THE HAZARD AS "CEREBROSPINAL FLUID (CSF) WITH LEACHABLES FLOWS BACK TO THE PATIENT VENTRICULAR/LUMBAR" WITH THE EFFECT (HARM) AS "ADVERSE TISSUE REACTION". BASED ON THE CONTROL MEASURE IN PLACE THE RESIDUAL RISK IS ACCEPTABLE. A CONTROL MEASURE LISTED WITHIN THE RISK FILE (DOC-035405 REV 06) "WARNING IN IFU/USER MANUAL TO INDICATE USE ONLY BY, OR UNDER THE DIRECTION OF, TRAINED MEDICAL PROFESSIONALS, INSTRUCTION IN DEVICE MANUAL/LFU TO PREVENT THE FLUID FLOWING BACK TO THE PATIENT". THE INSTRUCTIONS FOR USE (SD208650001 REV C) CONTAINS SEVERAL WARNINGS TO HELP PREVENT THIS FROM OCCURRING DURING CLINICAL USE: PAGE (3) THREE, WARNING STATES "LNTRACRANIAL PRESSURE IS CONTROLLED BY THE HEIGHT OF THE DRIP CHAMBER RELATIVE TO THE PATIENT. IT IS IMPORTANT THAT NEITHER THE DRIP CHAMBER NOR THE PATIENT BE RAISED OR LOWERED ACCIDENTALLY. IF EITHER IS RAISED OR LOWERED, IT IS IMPERATIVE TO RE-LEVEL THE DRAINAGE SYSTEM." PAGE (3) THREE, WARNING "THE HEIGHT OF THE DRIP CHAMBER OR THE POSITION OF THE PATIENT SHOULD ONLY BE CHANGED BY QUALIFIED PERSONNEL ON THE ORDERS OF A PHYSICIAN". "MOVEMENT BY THE PATIENT AFTER POSITIONING OF THE DRIP CHAMBER MAY AFFECT THE PATIENT'S ICP". PAGE (3) THREE, WARNING "CARE SHOULD BE TAKEN NOT TO RAISE OR LOWER THE DRIP CHAMBER WHEN CALCULATING THE DRAINAGE RATE". PAGE (5) FIVE, POSITIONING THE DRIP CHAMBER WARNING STATES: "LNTRACRANIAL PRESSURE IS CONTROLLED BY THE HEIGHT OF THE DRIP CHAMBER RELATIVE TO THE PATIENT. IT IS IMPERATIVE THAT NEITHER THE DRIP CHAMBER NOR THE PATIENT BE RAISED OR LOWERED ACCIDENTALLY". "MOVEMENT BY THE PATIENT AFTER POSITIONING OF THE DRIP CHAMBER MAY AFFECT THE PATIENT'S ICP". "LOOSEN THE WHITE SCREW AND SLIDE THE BLACK DRIP CHAMBER PRESSURE REFERENCE LINE TO THE APPROPRIATE PRESSURE SETTING IN MM HG OR CM H2O. TURN THE WHITE SCREW CLOCKWISE TO SECURE". PAGE (5) FIVE NOTE: "THE DRIP CHAMBER PRESSURE REFERENCE LINE CORRESPONDS TO THE FLUID OUTLET WITHIN THE DRIP CHAMBER. THE INLET TUBING HAS NO EFFECT ON THE PRESSURE SETTING BECAUSE BOTH SIDES OF THE TUBING ARE EQUIDISTANT TO ITS PEAK FROM THE PRESSURE SETTING ARROW". PAGE (5) FIVE, POSITION OF DRIP CHAMBER NOTE: "THE DESIGN OF THE NATUS EDS 3 SYSTEM PERMITS AIR TO ENTER AT THE DRIP CHAMBER MICROBIAL RETENTIVE ATMOSPHERIC VENT. THIS ALLOWS SETTING OF THE DRAINAGE PRESSURE BY MEANS OF THE DRIP CHAMBER HEIGHT AND PREVENTS SUCTION OR BACKPRESSURE FROM THE DOWNSTREAM LINE OR COLLECTION BAG FROM AFFECTING THE SETTING. IT IS NORMAL TO HAVE AIR IN THE TUBING DOWNSTREAM FROM THE DRIP CHAMBER". PAGE (7) SEVEN, DETERMINING THE DRAINAGE RATE, WARNING STATES THAT "CARE SHOULD BE TAKEN NOT TO RAISE OR LOWER THE DRIP CHAMBER WHEN CALCULATING THE DRAINAGE RATE". THE AMOUNT OF CSF DRAINAGE DEPENDS ON THE PRESSURE DIFFERENCE BETWEEN THE ICP AND THE HEIGHT OF THE DRIP CHAMBER. BASED ON THE INVESTIGATION FINDINGS, THE TWO DRAINS (REFER COMPLAINT NO. (B)(4), (B)(4)) WERE FUNCTIONING AS INTENDED. IT APPEARS THAT THE USERS FAILED TO FOLLOW THE WARNINGS AND MULTIPLE CAUTIONARY NOTES OUTLINED THROUGHOUT THE INSTRUCTIONS FOR USE. DEVICE FAILED TO MEET SPECIFICATIONS. NO. FAILURE MODE: CONFIRMED/ DEVICE FUNCTIONING AS INTENDED. CLOSURE RATIONALE: COMPLAINT COULD NOT BE VERIFIED, MONITOR FOR FUTURE OCCURRENCE. COMPLAINT WILL BE INCLUDED IN TRENDING DATA FOR FURTHER REVIEW.
NT821731C, EDS 3, GEN LL, NO CATHETER - CEREBRAL SPINAL FLUID (CSF) IS BACK FLOWING FROM THE TOP OF THE BURETTE. ACCORDING TO THE CUSTOMER, THE PATIENT DEVELOPED VENTRICULITIS, THE EVD CATHETER WAS CHANGED WITH NEW DRAINAGE SYSTEM. IT WAS CONNECTED TO THE PATIENT; AIR BEGAN TO BACKFLOW FROM THE DRAINAGE CHAMBER TOWARDS THE PATIENT. THE CUSTOMER ATTEMPTED TO TROUBLESHOOT WITHOUT SUCCESS. THE CUSTOMER CHANGED OUT THE SYSTEM WITH A NEW SYSTEM. THE CUSTOMER CONFIRMED THERE WAS NO DELAY IN SURGERY.
NT821731C, EDS 3, GEN LL, NO CATHETER - CEREBRAL SPINAL FLUID (CSF) IS BACK FLOWING FROM THE TOP OF THE BURETTE. ACCORDING TO THE CUSTOMER, THE PATIENT DEVELOPED VENTRICULITIS, THE EVD CATHETER WAS CHANGED WITH NEW DRAINAGE SYSTEM. IT WAS CONNECTED TO THE PATIENT; AIR BEGAN TO BACKFLOW FROM THE DRAINAGE CHAMBER TOWARDS THE PATIENT. THE CUSTOMER ATTEMPTED TO TROUBLESHOOT WITHOUT SUCCESS. THE CUSTOMER CHANGED OUT THE SYSTEM WITH A NEW SYSTEM. THE CUSTOMER CONFIRMED THERE WAS NO DELAY IN SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 861289 | NT821731C, EDS 3, GEN LL, NO CATHETER | NT821731C, EDS 3, GEN LL, NO CATHETER | JXG | NATUS MEDICAL INCORPORATED | NT821731C | 118000977575 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Female |