Summary of MedSun Reports Describing Adverse Events With Arthroscopy Pumps
MedSun: Newsletter #53, October 2010

Arthroscopic pumps are devices that irrigate and inflate joint spaces by delivering fluid at an appropriate pressure and flow rate, during diagnostic and operative arthroscopic procedures.

During arthroscopic surgery, the joint is continuously irrigated with saline fluid which is pressurized to create joint distension. Saline fluid flow removes disturbances in the arthroscopic view which may include excess bleeding, air bubbles or synovial fluid. Improving visibility of the joint capsule is essential to performing arthroscopic procedures safely and efficiently (p. 590, 2008, Tuijthof).

Over the past 2 years, MedSun has received 13 adverse event reports associated with arthroscopy pumps manufactured by Arthrex Inc, Stryker Endoscopy Inc, and CONMED Linvatec (ConMed Corporation), The reports were submitted by 10 hospitals between July 2008 and May 2010.

The reported device problems were:
• Over-irrigation of operative space (9)
• Continuous high pressure alarm condition (1)
• Sensor malfunction (1)
• Device-system disassembly (1)
• System cable malfunction (1)

None of the reported incidents involved a patient death. The patient problems listed below were reported in 11 of the 13 reports.
• Fluid extravasation /edema (7)
• Compromised circulation (4)

Of the reports that listed patient age, 1 had a patient age listed as less than 21 years and 9 had a patient age listed as greater than 21 years. Of the reports that listed patient gender, a total of 7 reports involved female patients and a total of 4 reports involved male patients.


The following table lists the MedSun reports that are described in the device problem summary above.

[Note: The reports have been edited for clarity]

Adverse Event Table
Device IdentifiersCatalog/Model/Lot Number Event Description
ARTHREX, INC. CONTINUOUS WAVE III AR-6475 DURING A KNEE ARTHROSCOPY, A MALFUNCTION OF THE EQUIPMENT RESULTED IN THE INFUSION OF THE INCORRECT AMOUNT OF FLUID INTO THE KNEE AND SURROUNDING TISSUE.
STRYKER ENDOSCOPY THE NURSE REPORTED DURING THE SURGEON'S FIRST CASE OF THE DAY, A SHOULDER ARTHROSCOPY, IT WAS NOTED THE PUMP WAS USING AN EXCESSIVE AMOUNT OF ARTHROSCOPY FLUID (34 BAGS TOTAL). THE PUMP WAS RECALIBRATED PARTWAY THROUGH THE CASE AND SEEMED TO WORK BETTER. FOR THE SURGEON'S SECOND CASE OF THE DAY, A DIFFERENT PUMP (BUT SAME MAKE/MODEL) WAS USED AND THE SAME PROBLEMS BEGAN TO OCCUR. THE DOCTOR MADE THE DECISION TO CONTINUE OPERATION WITH GRAVITY FLUID RATHER THAN CONTINUE USING THE PUMPS DUE TO SAFETY CONCERNS. THE FIRST PATIENT HAD A MODERATE AMOUNT OF FLUID EXTRAVASATION TO RIGHT SHOULDER AND BREAST, YET NOT UNUSUAL FOR THIS TYPE OF SURGERY. IT APPEARED THERE WAS NO SIGNIFICANT OR UNEXPECTED INJURY TO THE PATIENTS. HOWEVER, IT DOES APPEAR THE PUMPS MAY HAVE ISSUES WITH MAINTAINING THEIR CALIBRATIONS. OF NOTE, A PREVIOUS REPORT, WITH THE SAME ISSUE/EQUIPMENT WAS FILLED, WHICH REQUIRED EXTENDED HOSPITAL STAY.
ARTHREX, INC. AR-6400 PATIENT UNDERWENT RT. ANKLE ARTHROSCOPY AND CALCANEAL NONUNION EXCISION. IMMEDIATELY POSTOPERATIVELY IT WAS FOUND THAT THE PATIENT HAD RT. LOWER EXTREMITY COMPARTMENTS WITH NO PULSE OF DORSALIS PEDIS ARTERY. ARTERIAL DOPPLER CONFIRMED. IMMEDIATE FASCIOTOMY OF RT. LOWER EXTREMITY RELEASED 4 COMPARTMENTS OF THE LEG AND PULSES IMMEDIATELY RETURNED. PT TRANSFERRED TO MAIN HOSPITAL AND ADMITTED. TWO DAYS LATER, PATIENT UNDERWENT IRRIGATION AND DEBRIDEMENT AND CLOSURE OF RT. LOWER EXTREMITY WOUND. DISCHARGED IN GOOD CONDITION.
ARTHREX, INC. CONTINUOUS WAVE III AR-6475 DURING THE PROCEDURE (9 MINUTES INTO THE TOURNIQUET TIME), THE THIGH WAS NOTED TO BE EXTREMEMLY HARD AND THE PHYSICIAN NOTED SWELLING IN THE LEFT THIGH. THE TOURNIQUET WAS DEFLATED IMMEDIATELY. THE SWELLING DID SUBSIDE AFTER WRAPPING THE THIGH AS FLUID WAS RELEASED. THE MANUFACTURER'S REPRESENTATIVE DID EVALUATE THE DEVICE AND NOTED A LEVER THAT WAS FROZEN AND WOULD NOT MOVE BUT THIS WAS NOT FELT TO HAVE EFFECTED THE PROPER FUNCTIONING OF THE PUMP. THE PATIENT WAS TAKEN TO RECOVERY IN STABLE CONDITION WITH NO SIGNS OF COMPARTMENT SYNDROME.
ARTHREX, INC. CONTINUOUS WAVE III PUMP SENSOR NOT SENSING THE PRESSURE IN THE PATIENT'S SHOULDER LIKE IT SHOULD HAVE RESULTING IN EXTRAVASATION OF FLUID INTO THE SHOULDER JOINT.
STRYKER ENDOSCOPY, StrykeFlow II *,*,09133FG2 THE TIP ATTACHED TO THE IRRIGATION PUMP FROM THE SOLUTION SLIPPED OFF & THE SALINE SPILLED & THE TIP FELL ON THE FLOOR. THE PUMP ALSO FELL ON THE FLOOR.
ConMed Linvatec 87k DURING A KNEE ARTHROSCOPY PROCEDURE, THE PUMP PRESSURE WAS SET W/ DISTENTION PRESSURE OF 30. SURGICAL TEAM NOTED THE PT'S LEG WAS FIRM. WHEN PUMP SETTINGS CHECKED, THE PUMP INDICATED A PRESSURE SETTING OF 30 BUT ACTUAL PRESSURE MEASURED WAS 130. THE MD IMMEDIATELY BROUGHT SETTING DOWN TO 23, AT WHICH TIME THE PUMP SEEMED TO REGULATE ITSELF. A THREE LITER IRRIGATION BAG WHICH HAD JUST BEEN HUNG WAS FOUND EMPTY. THE PT HAD NOTICEABLE EDEMA FROM KNEE LEVEL TO LEFT LOWER QUADRANT DOWN INTO PERINEUM. PT DID NOT HAVE COMPROMISED CIRCULATION IN LEG/FOOT. A SIGNIFICANT AMOUNT OF THE SWELLING RESOLVED PRIOR TO THE PATIENT'S DISCHARGE.
THE PUMP WAS ISOLATED AND TESTED INTERNALLY, AND FOUND TO BE FUNCTIONING AS EXPECTED. THE DISPOSABLE TUBING/CASSETTE WERE NOT SAVED AND IS NOT AVAILABLE FOR TESTING.
THE HANDPIECE/CABLE USED DURING THIS CASE WERE NOT ISOLATED. THE HOSPITAL HAS 9 HANDPIECES/CABLES, SO ALL 9 WERE TESTED. TWO WERE FOUND TO HAVE CABLES THAT DID NOT FUNCTION AS EXPECTED. (ONE WAS UNRESPONSIVE TO THE BUTTONS, ONE DID NOT SENSE ANYTHING). THESE HAVE BEEN REPLACED. ONE HAND SWITCH WAS FOUND TO NOT FUNCTION PROPERLY. IT WAS FOUND TO HAVE BUILD UP UNDER THE BUTTONS. IT WAS CLEANED, AND HAS NOT YET BEEN RE-TESTED FOR FUNCTION.

IT WAS UNABLE TO BE DETERMINED BY THE HOSPITAL IF EITHER OF THE CABLES OR THE HAND SWITCH WERE INVOLVED IN THE REPORTED INCIDENT.
STRYKER ENDOSCOPY, Flosteady 350-800-001 STRYKER ENDOSCOPIC FLOSTEADY IRRIGATION MACHINE SEEMED TO BE MALFUNCTIONING. MACHINE CATALOG NUMBER 350-800-001. THE MACHINE PRESSURE SPIKED AND CAUSED INCREASED FLUID IN THE RIGHT KNEE OF THE PATIENT. SMALL AMOUNT OF FLUID ACCUMULATED IN THE KNEE TISSUE. NO SEVERE OR PERMANENT INJURY WAS CAUSED, ONLY SOME SLIGHT TISSUE EDEMA.

MANUFACTURER RESPONSE (AS PER REPORTER) FOR IRRIGATION/DISTENTION SYSTEMS, ARTHROSCOPIC, (BRAND NOT PROVIDED)

A STRYKER REP POINTED OUT THAT THERE COULD BE SOME LAG TIME FROM PUSHING THE "SURGE' BUTTON ON THE REMOTE TO THE UNIT. NOT MUCH TIME TO AFFECT IT, BUT THERE IS A NEW SOFTWARE UPDATE THAT HE IS LOOKING IN TO GETTING. HE ALSO STATED THAT WHEN THIS WAS AVAILABLE STRYKER WILL UP GRADE ALL OF THESE UNITS IN THE HOSPITAL
ARTHREX, INC. AR-6410 DURING SHOULDER ARTHROSCOPIC PROCEDURE, THE ARTHREX ARTHROSCOPY PUMP WAS UTILIZED. IT WAS SET UP PER MANUFACTURER RECOMMENDATIONS. APPROXIMATELY 10 MINUTES INTO THE PROCEDURE, THE PRESSURE ALARM SOUNDED. (PRESSURE WAS SET AT 35 MMHG WITH AS HIGH AS 50MMHG RECOMMENDED). SURGEON NOTED OPERATIVE SHOULDER APPEARED TO BE ABSORBING FLUID IN LOCALIZED AREA AND INTO AXILLA. TUBING WAS CHECKED AND PUMP RESTARTED SEVERAL TIMES FOR ONLY BRIEF MOMENTS BEFORE MACHINE WOULD CYCLE OFF. TUBING WAS TOTALLY SWITCHED OVER FOR NEW TUBING PER MANUFACTURER RECOMMENDATIONS. NEW TUBING APPEARED TO RESOLVE PROBLEM. ARTHROSCOPIC PROCEDURE WAS FINALLY ABORTED AFTER ABOUT 10 MINUTES BECAUSE OF FLUID EXTRAVASATION,(CONSENT WAS FOR ARTHROSCOPIC AND OPEN SHOULDER). PROCEDURE THEN WAS COMPLETED WITHOUT FURTHER INCIDENT. MD EXAMINED PT POST OP AND NOTED THAT RETAINED FLUID WAS RESOLVING. PT TO PACU IN STABLE CONDITION.
ConMed Linvatec 87k THE PATIENT IS AN ADULT WHO UNDERWENT ARTHROSCOPY OF THE LEFT KNEE. IT WAS DISCOVERED THE PATIENT HAD A MARKEDLY SWOLLEN LEFT THIGH FOLLOWING THE ARTHROSCOPIC PROCEDURE AND ABSENT PULSES IN THE LEFT FOOT. EXAMINATION REVEALED SEVERE LEFT THIGH SWELLING IN A DIFFUSE FASHION. THERE WERE NO PALPABLE OR DOPPLERABLE ANKLE OR FOOT PULSES. INFILTRATION OF LACTATED RINGERS OR POSSIBLE AN ARTERIAL INJURY COULD NOT BE ABSOLUTELY RULED OUT. THE PATIENT WAS PREPARED FOR LEFT LOWER EXTREMITY ARTERIOGRAPHY AND POSSIBLE FASCIOTOMY OF THE THIGH. THE VASCULAR SURGEON TOOK PATIENT TO MAIN OR FOR ARTERIOGRAM, ELEVATION MAINTAINED FOR TRANSPORT, COLOR RETURNING TO LEFT FOOT PRIOR TO TRANSPORT, TRANSPORTED WITH CRNA, ANESTHESIOLOGISTS, AND 2 RN'S, PUMP RUNNING THROUGHOUT PROCEDURE WITHOUT DIFFICULTY OR ALARMS AT PRESSURE OF 50 AND FLOW OF MEDIUM, APPROX 5.5 BAGS OF 5 LITER LR RUN THROUGH CASE. SHE WAS TAKEN FROM THE OUTPATIENT SURGICAL CENTER TO THE MAIN OPERATING ROOM AND UNDERWENT ARTERIOGRAPHY VIA RIGHT FEMORAL GROIN APPROACH. FORTUNATELY, THIS STUDY WAS UNREMARKABLE FOR INJURY PER SE TO THE VASCULAR TREE. THE PATIENT'S LEFT LOWER EXTREMITY WAS MAINTAINED AT MAXIMUM ELEVATION, AND HER SOFT TISSUE DISTENTION GRADUALLY ABATED WITH RETURN OF NORMAL FOR VASCULAR FLOW. IT WAS FELT THAT THIS PATIENT SHOULD BE HOSPITALIZED OVERNIGHT FOR CLOSE OBSERVATION AND MONITORING PURPOSES AND WAS DISCHARGED THE FOLLOWING DAY.
ARTHREX, INC. CONTINUOUS WAVE III AR-6457 THE CASE BEGAN IN USUAL MANNER. THE FIELD TURNED BLOOD TINGED. THE SURGEON INSTRUCTED THE SCRUB TO HOLD THE FLUSH BUTTON UNTIL INSTRUCTED TO RELEASE. THE FLUSH BUTTON WAS HELD INTERMITTENTLY FOR SEVERAL MINUTES AT A TIME THROUGHOUT THE PROCEDURE. THE CASE WAS COMPLETED WITH A TOTAL OF 47,250 ML OF SALINE USED. DRESSINGS WERE APPLIED AND DRAPES WERE REMOVED. UPON DRAPE REMOVAL, EDEMA WAS NOTED TO LEFT SHOULDER, LEFT BREAST, LEFT AXILLA, ANTERIOR/POSTERIOR NECK, FACE, SCALP, AND LEFT EAR. SKIN WAS INTACT BUT VERY HARD/TAUNT. THE SURGEON WAS NOTIFIED AND INSTRUCTED TO POSITION PATIENT IN FOWLER'S POSITION. THE ANESTHESIOLOGIST INSTRUCTED THE CRNA TO KEEP THE ENDOTRACHEAL TUBE IN PLACE. PATIENT WAS REPOSITIONED INTO FOWLERS POSITION ON THE STRETCHER AND TRANSFERRED TO PACU.
ConMed Linvatec 87k PATIENT ADMITTED FOR ELECTIVE DIAGNOSTIC SURGICAL ARTHROSCOPY OF THE LEFT KNEE DUE TO HISTORY OF INTERNAL DERANGEMENT OF THE LEFT KNEE. THIS WAS COMPLICATED BY THE DISCOVERY, AT THE TIME OF DRESSING APPLICATION, OF SIGNIFICANT ISCHEMIA OF THE LEFT LOWER EXTREMITY BROUGHT ON BY RINGER'S LACTATE EXTRAVASATION INTO THE LEFT THIGH, COMPRESSING THE FEMORAL ARTERY. THE PATIENT WAS SEEN IN IMMEDIATE CONSULTATION BY VASCULAR SERVICE. SHE WAS TAKEN FROM THE OUTPATIENT SURGICAL CENTER TO THE MAIN OPERATING ROOM AND UNDERWENT ARTERIOGRAPHY VIA RIGHT FEMORAL GROIN APPROACH. FORTUNATELY, THIS STUDY WAS UNREMARKABLE FOR INJURY PER SE TO THE VASCULAR TREE. THE PATIENT'S LEFT LOWER EXTREMITY WAS MAINTAINED AT MAXIMUM ELEVATION, AND HER SOFT TISSUE DISTENTION GRADUALLY ABATED WITH RETURN OF NORMAL FOR VASCULAR FLOW. IT WAS FELT THAT THIS PATIENT SHOULD BE HOSPITALIZED OVERNIGHT FOR CLOSE OBSERVATION AND MONITORING PURPOSES. ON THE PATIENT'S FIRST POSTOPERATIVE DAY, THE WOUNDS ARE CLEAN, DRY AND HEALING ABOUT THE LEFT KNEE AREA. SHE HAS NO EVIDENCE FOR VASCULAR IMPAIRMENT TO THE LEFT LOWER EXTREMITY. HER THIGH IS SOFT. SHE HAS NO NOTABLE PROBLEMS IN THE RIGHT GROIN. THE PATIENT HAS BEEN UP OUT OF BED AND AMBULATORY TO THE BATHROOM WITH CRUTCH ASSIST. SHE IS REASONABLY COMFORTABLE. SHE WILL BE DISCHARGED TO HOME, TO BE SEEN IN ORTHOPEDIC FOLLOWUP IN 12 TO 14 DAYS' TIME.

ON DAY OF ORTHO FOLLOW UP: ON EXAMINATION TODAY THE PATIENT IS ABLE TO AMBULATE WITH ONLY SLIGHT ANTALGIA ON THE LEFT. HER THIGH APPEARS TO BE EQUAL IN SIZE TO HER RIGHT AND THERE DOES NOT APPEAR TO BE ANY ECCHYMOSIS IN THE LEFT THIGH AREA. HER WOUND INCISION SITES REMAIN CLEAN AND DRY AND HER SUTURES ARE REMOVED TODAY UNDER STERILE TECHNIQUE AND STERI-STRIPS ARE PLACED ACROSS THE WOUND SITE OVER BENZOIN. STATED BEFORE SHE DID HAVE SOME NUMBNESS IN THE THIGH FROM THE GROIN TO THE KNEE BUT THIS APPEARS TO BE RESOLVING AND VERY LITTLE PAIN REMAINING WITHIN THE LEFT KNEE ITSELF. ISOMETRIC EXERCISES RECO
STRYKER ENDOSCOPY 350-357-000/AO2 THE CASE WAS STARTED AT 10:23. EDEMA AND INCREASE IN PEAK PRESSURE NOTED AT 1120. SURGEON INFORMED AND PROCEEDED TO WORK. ARTHROSCOPY PUMP RAN AT 80 AND 1.0 FOR MAJORITY OF CASE. TOTAL SALINE USED WAS 55,750ML. SALINE RETURN EQUALED 42,250ML WITH A LARGE AMOUNT OF SALINE ON THE FLOOR UNCOLLECTABLE. SALINE DEFICIT NOTED AT 14,500ML. UPON DRAPE REMOVAL, EDEMA WAS NOTED TO BILATERAL BREAST, AROUND NECK, LEFT EAR, AND BACK OF SCALP. PATIENT WAS MOVED TO STRETCHER AND PLACED IN SITTING POSITION. PATIENT REMAINED INTUBATED AND TRANSPORTED TO PACU AT 1208. AS OF DAY AFTER THE CASE, PATIENT REMAINED INTUBATED IN THE ICU.


Additional Information:

Tuijthof, G.J.M., Boomen, H. Van Den, Heerwarden, R. J. van Heerwaarden, & Dijk, C.N. van. (2008). Comparison of two arthroscopic pump systems based on image quality. Knee Surg Sports Traumatol Arthrosc, 16, 590-594.


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