BEUDAMED
    FDA Adverse Event Other Summary report: N

    FLOWTRON EXCEL/TRIO PUMPS

    MDR report key: 2676189 · Received July 25, 2012

    Report

    Report Number
    3005619970-2012-00006
    Event Type
    Other
    Date Received
    July 25, 2012
    Report Date
    June 26, 2012
    Manufacturer
    GETINGE (SUZHOU) CO. LTD.
    Product Code
    JOW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS BEING FILED UNDER EXEMPTION ((B)(4)) BY ARJOHUNTLEIGH INC. ON BEHALF OF THE MANUFACTURER (GETINGE (B)(4)). ARJOHUNTLEIGH STRIVE TO PROVIDE PRODUCTS WHICH PERFORM TO THE HIGHEST CLINICAL AND SAFETY STANDARDS, BASED ON THE BEST AVAILABLE EVIDENCE AND WHICH, GIVEN THE LACK OF CLEAR EVIDENCE LINKED TO SIDE EFFECTS, ERR ON THE SIDE OF CAUTION WITH REGARD TO OUR RECOMMENDATIONS: THIS IS PARTICULARLY IMPORTANT AS WE PROVIDE MEDICAL DEVICES TO A ADVERSE GLOBAL MARKET WHERE CLINICAL SUPERVISION AND MEDICAL PRACTICE VARIES WIDELY. ESSENTIALLY, IPC HAS PROVEN TO BE A VERY SAFE AND EFFECTIVE METHOD OF PREVENTING VTE; SIDE EFFECTS ARE RARE AND THERE IS LITTLE EVIDENCE TO SUGGEST THAT SIGNIFICANT ADVERSE EVENTS CAN BE ATTRIBUTED TO IPC WHEN USED UNDER MEDICAL SUPERVISION AND IN ACCORDANCE WITH MANUFACTURERS' INSTRUCTIONS. EVIDENCE IN MANY AREAS OF HEALTHCARE IS NOT ALWAYS ROBUST OR CONCLUSIVE AND IPC IS NO DIFFERENT. AS COMMENTED ON BY THIS CUSTOMER (UOM), WE TOO AS A MANUFACTURER HAVE TO "DO THE RIGHT THING" AND AS SUCH ARJOHUNTLEIGH PROVIDE BROAD BASED INDICATIONS, CAUTIONS AND CONTRAINDICATIONS FOR ALL OF OUR PRODUCTS SO THAT THESE CAN BE USED TO ASSIST IN MAKING CONFIDENT DECISIONS ABOUT TREATMENT OPTIONS. HOWEVER, ULTIMATELY WHETHER TO USE OR NOT USE A PRODUCT/UNDERTAKE A CLINICAL INTERVENTION ETC COMES DOWN TO CLINICIAN AS ONLY THEY CAN MAKE A CLINICAL JUDGEMENT BASED ON INDIVIDUAL PT AND HOLISTIC ASSESSMENT. CONCLUSION: IT IS OUR (ARJOHUNTLEIGH) POSITION THAT THE 'CAUTIONS' AND 'CONTRAINDICATIONS' LISTED IN OUR CURRENT IFUS FOR IPC/DVT PRODUCTS SUPPORT THE SAFE USE AND WELL BEING OF THE PTS. WE ACKNOWLEDGE THE CONCERNS OF THE UNIVERSITY (B)(6), HOWEVER BASED ON THE INFO GATHERED TO DATE, SEE NO REASON TO INCLUDE THE TWO PROPOSED CONTRAINDICATIONS (COMPARTMENT SYNDROME OF THE AFFECTED EXTREMITY AND FRACTURE OF THE AFFECTED EXTREMITY) TO OUR IFUS. WE HAVE REVIEWED THE CONCERNS OVER THE USE OF IPC IN THE PRESENCE OF SUSPECTED OR DIAGNOSED COMPARTMENT SYNDROME, BUT SEE THIS AS A "CAUTIONARY" CONCERN AND NOT A CONTRAINDICATION. WHEN AFTER REVIEWING SIMILAR PRODUCTS ON THE MARKET, WE (AH) CAN CONFIRM THAT THEY ALSO APPEAR TO FOLLOW THE SAME CONTRAINDICATIONS. IN THE PAST 5 YEARS, THERE HAS ONLY BEEN ONE EVENT WHICH FALLS UNDER THE CONCERN OF 'COMPARTMENT SYNDROME' (REF: 3005619970-2012-00003). AGAIN, THERE WAS NO EVIDENCE TO SUGGEST THAT OUR PRODUCT CONTRIBUTED TO THE DEVELOPMENT OF CS. IN 5 YEARS, WE HAVE PRODUCED APPROX. (B)(4) GARMENTS GLOBALLY WITH ONLY ON OCCURRENCE LINKED TO CS (WITH NO EVIDENCE). WE WILL OF COURSE CONTINUE TO MONITOR ALL EVENTS OF THIS FAILURE IN OUR TRENDING SYSTEM TO ESTABLISH ANY PATTERN OCCURRING AND REACT APPROPRIATELY.

    Description of Event or Problem · 1

    SEQUENTIAL COMPRESSION DEVICES (CDS) ARE USED AS A PART OF OUR PREVENTION STRATEGIES FOR DVT/PE (DEEP VEIN THROMBOSIS/PULMONARY EMBOLISM). IN PTS WHERE THERE ARE CONTRAINDICATIONS TO PHARMACOLOGIC PROPHYLAXIS, IT IS THEIR ONLY DEFENCE. AS SUCH, WE HAVE PUT A GREAT DEAL OF ENERGY LATELY INTO IMPROVING COMPLIANCE WITH SCDS, AND HAVE DONE A LOT RELATED TO NURSING EDUCATION. THE HOSPITAL HAS A COMMITTEE THAT SPECIFICALLY OVERSEES APPLICATIONS AND USAGE OF SCDS. IT RECENTLY CAME TO OUR ATTENTION THAT MANY OUTSIDE ONLINE MEDICAL REFERENCES, SUCH AS "MOSBY'S" (TO WHICH OUR NURSING OFTEN REFERS) THAN WHAT WE AS A COMMITTEE FEEL IS MOST APPROPRIATE AND SAFEST FOR OUR PTS. TO COMPLICATE MATTERS FURTHER, THE MODEL WE CURRENTLY USE ALSO HAS A LIST OF CONTRAINDICATIONS IN THE MANUAL/PACKAGE INSERT THAT DO NOT AGREE WITH OUR COMMITTEE'S JUDGMENT FOR TRUE CONTRAINDICATES. WE HAVE A LIST OF WHAT IS "THE RIGHT THING TO DO," FROM A SOUND MEDICAL PERSPECTIVE, THAT DISAGREES WITH MULTIPLE PUBLISHED SOURCES, AND THEREFORE WE ARE HESITANT TO MOVE FORWARD WITH AN INSTITUTIONAL POLICY THAT COULD PUT OUR ORGANIZATION OR INDIVIDUAL PROVIDERS AT RISK MEDICO-LEGALLY. FOR EXAMPLE, MANY OF THIS RESOURCES STATE THAT "KNOWN OR SUSPECTED ACUTE DVT" IS A CONTRAINDICATION WHICH IS NOT SUPPORTED BY THE SCIENCE. ONE OF OUR VASCULAR SURGEONS STATED "IT'S NOT LIKE A LEG WITH A CLOT IS LIKE A TUBE OF TOOTHPASTE WHERE WE COULD SQUEEZE IT OUT." THIS RECOMMENDATION HARKENS BACK TO THE DAYS WHEN WE PRESCRIBED STRICT BACK REST FOR PTS WITH ACUTE DVT, AND MEDICAL CARE AND OUR UNDERSTANDING HAS EVOLVED SIGNIFICANTLY SINCE THEN (THOUGH MANY STILL HANG ON TO SOME OLD BELIEFS). TODAY, WE NEVER LIMIT A PTS AMBULATION WITH ACUTE DVT. IN FACT, AMBULATION IS THE CORNERSTONE, AND AMBULATION SIGNIFICANTLY CAUSES MORE PRESSURE WITHIN THE CALF VEINS THAN SCDS WOULD. SIMILARLY STANDARD OF CARE IS TO PRESCRIBE COMPRESSION STOCKINGS TO BE WORN IMMEDIATELY AFTER DIAGNOSIS, FOR TWO YEARS DURATION, FOR ALL HOURS EXCEPT SLEEPING. THE STRENGTH RECOMMEND IS 30-40MM HG, AND OUR FLOWTRON SCDS ARE SET TO 40MMHG PRESSURE INTERMITTENTLY. SHOCKINGLY, THE MANUFACTURE AND MOSBY'S HAVE LEFT OFF TWO OF THE MOST CRITICAL CONTRAINDICATIONS SUCH AS COMPARTMENT SYNDROME OR FRACTURE OF THE AFFECTED EXTREMITY. HERE IS THE COMMITTEE'S PROPOSED LIST OF CONTRAINDICATIONS: SEVERE PERIPHERAL VASCULAR DISEASE [ABPI] ANKLE BRACHIAL PRESSURE INDEX) <0.5]; CLASS IV CHF (CONGESTIVE HEART FAILURE) (USE WITH CAUTION IN CLASS III CHF WITHOUT VOLUME OVERLOAD); COMPARTMENT SYNDROME OF THE AFFECTED EXTREMITY; FRACTURE OF THE AFFECTED EXTREMITY; LOCAL CONDITIONS SUCH AS: GANGRENE, RECENT SKIN GRAFT, OR OPEN WOUND OF THE AFFECTED EXTREMITY. OUR COMMITTEE IS FACED WITH THE DILEMMA: DO WE "DO THE RIGHT THING" MEDICALLY FOR OUR PTS, UNDERSTANDING WE MIGHT INVITE CONTROVERSY AND NEED TO DEFEND OUR POSITION? OR DO WE NEED TO STICK TO THE MANUAL/PACKAGE INSERT ON THIS IN ORDER TO PROTECT THE HOSPITAL AND OUR PROVIDERS FROM LITIGATION?

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLOWTRON EXCEL/TRIO PUMPS DVT JOW GETINGE (SUZHOU) CO. LTD. 247001

    Patients

    Seq Age Sex Outcome Treatment
    1