FLOWTRON ACS 900
Report
- Report Number
- 3005619970-2017-00001
- Event Type
- Injury
- Date Received
- January 5, 2017
- Date of Event
- December 2, 2016
- Report Date
- April 12, 2018
- Manufacturer
- GETINGE (SUZHOU) CO., LTD.
- Product Code
- JOW
- Removal / Correction Number
- FSN-SUZ-001-2017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
THIS REPORT IS BEING FILED UNDER EXEMPTION E2012066 BY GETINGE (SUZHOU) CO., LTD. (REGISTRATION #(B)(4)) ON BEHALF OF THE IMPORTER (B)(4). ADDITIONAL INFORMATION WILL BE PROVIDED UPON THE INVESTIGATION CONCLUSION.
THIS REPORT IS BEING FILED UNDER EXEMPTION E2012066 BY GETINGE (SUZHOU) CO., LTD. (REGISTRATION #(B)(4)) ON BEHALF OF THE IMPORTER ARJOHUNTLEIGH, INC. AHUS (REGISTRATION #(B)(4)). THE FACILITY HAS DECIDED TO PERFORM THEIR OWN INVESTIGATION ON THE INVOLVED FLOWTRON SYSTEM.ALTHOUGH SEVERAL ATTAMPTS OF CONTACT WERE MADE, IT WAS NOT POSSIBLE TO GATHER ANY ADDITIONAL INFORMATION TO DATE. THE LAST ATTEMPT OF CONTACT (A VISIT AT THE FACILITY) TOOK PLACE ON (B)(6) 2017. EXPECTED DATE DUE FOR THE NEXT REPORT IS ESTIMATED AS (B)(6) 2017.
THIS IS A FOLLOW-UP 4 REPORT TO THE FOLLOW-UP 3 REPORT (MANUFACTURER REPORT NUMBER: 3005619970-2017-00001). ARJO HAS CONTINUED THE INVESTIGATION TOWARDS FLOWTRON ACS900 DEFLATION FAILURE AND WAS ABLE TO REPLICATE THE REPORTED FAULT. THIS ALLOWED TO IDENTIFY THE ROOT CAUSE OF THE INVESTIGATED PROBLEM. GARMENT OVER INFLATION OCCURS WHEN THE FLOWTRON ACS900 PUMP IS ENTERED TO THE STATE IN WHICH IT EXPERIENCES A SPECIFIC NUMBER OF POWER ON/OFF CYCLES. THE ISSUE IS CAUSED A TIMER OPERATING SYSTEM RESOURCE BEING OVER ALLOCATED. THE SYMPTOM OF THE INVESTIGATED PROBLEM REVEALS WHEN THE FINAL POWER ON SEQUENCE BEGINS. IT WAS FOUND OUT THAT THIS PROBLEM MAY OCCUR IN THE FIELD IN A NUMBER OF WAYS: MEMBRANE KEYPAD HARDWARE FAILURE. USERS PRESSING THE POWER BUTTON QUICKLY. THE POWER BUTTON BEING USED AS A THERAPY START/ STOP BUTTON. THE MOST LIKELY SCENARIO IS THAT THE POWER BUTTON IS USED TO STOP AND THEN START THE THERAPY. NOTE THAT IT HAS ALWAYS BEEN INTENDED THAT THE END USER SHOULD USE THE CENTER PLAY / PAUSE BUTTON TO START AND STOP THERAPY. EVERY TIME THE POWER BUTTON IS USED TO START THERAPY, A NEW TIMER OPERATING SYSTEM RESOURCE IS CREATED, LEADING TO A SOFTWARE FAULT. VERSION 2.000 SOFTWARE FORCES THE PUMP TO COMPLETELY RESET WHENEVER THE OPERATING SYSTEM FAILURE OCCURS. THIS RESULTS IN THERAPY BEING RESTARTED AND PREVENTS AN ATTACHED DVT GARMENT FROM FAILING TO DEFLATE. THE PUMP CONTINUES THE THERAPY AFTER THE RESET. WE HAVE CONFIRMED THAT THE SPECIFIC SYMPTOM OBSERVED IN THE FIELD CAN BE ADDRESSED BY UPGRADING DEVICES TO SOFTWARE VERSION 2.000.
THIS REPORT IS BEING FILED UNDER EXEMPTION E2012066 BY GETINGE (SUZHOU) CO., LTD. (REGISTRATION #(B)(4) ON BEHALF OF THE IMPORTER ARJOHUNTLEIGH, INC. AHUS (REGISTRATION #(B)(4)). AN INVESTIGATION WAS CARRIED OUT INTO THIS COMPLAINT. ON 07 DEC 2016 ARJOHUNTLEIGH WAS INFORMED ABOUT AN INCIDENT WHICH OCCURRED DURING THE USE OF FLOWTRON ACS900 PUMP. IT WAS INDICATED THAT A (B)(6) PATIENT DEVELOPED A COMPARTMENT SYNDROME WHILE USING THE FLOWTRON SYSTEM AND REQUIRED A FASCIOTOMY PROCEDURE TO BE PERFORMED. AT THE TIME OF COMPRESSION THERAPY THE PATIENT WAS UNDERGOING MAXILLOFACIAL SURGERY WHICH LASTED FOR 2 HOURS AND WAS PLACED IN THE SUPINE POSITION DURING THE PROCEDURE. WHEN REVIEWING SIMILAR REPORTABLE EVENTS ON DVT COMPRESSION SYSTEMS, WE HAVE FOUND A NUMBER OF EVENTS PRESENTING A SIMILAR SCENARIO AS CLAIMED IN THIS COMPLAINT. ALL OF THE IDENTIFIED CASES REGARDED PATIENT'S OUTCOMES OF A COMPARTMENT SYNDROME DEVELOPED AFTER SURGICAL PROCEDURES LASTING AT LEAST 2 HOURS. THE OCCURRENCE RATE OBSERVED FOR THIS FAILURE MODE IS CURRENTLY CONSIDERED TO BE VERY LOW. THE FLOWTRON DVT PREVENTION SYSTEMS ARE BE USED AS PART OF A PRESCRIBED PLAN OF CARE, AN INDIVIDUALIZED MONITORING PROGRAM AND ARE INTENDED FOR USE ONLY IN PROFESSIONAL HEALTHCARE FACILITIES. FLOWTRON ACS900 INCORPORATES A VARIETY OF ALARMS AND WARNING WHICH SHOULD ALERT THE CAREGIVER OF ANY PROBLEM WITH THE THERAPY. BASING ON THE INFORMATION RECEIVED ALONG WITH THE NOTIFICATION ABOUT THE EVENT, NO ALLEGATION IN TERMS OF PRODUCT FUNCTIONALITY OR USE WAS STATED BY THE FACILITY. THE INVOLVED FLOWTRON SYSTEM WAS ISOLATED AND EVALUATED BY THEIR BIOMED DEPARTMENT, HOWEVER NEVER MADE AVAILABLE FOR ARJOHUNTLEIGH'S EVALUATION. IN ORDER TO OBTAIN ADDITIONAL INFORMATION WHICH WOULD ALLOW FOR A THOROUGH INVESTIGATION OF THE CASE, ALTHOUGH ARJOHUNTLEIGH HAS MADE SEVERAL ATTEMPTS OF CONTACTING THE FACILITY (USING DIFFERENT COMMUNICATION CHANNELS), NO RESULTS OF DEVICE EXAMINATION RESULTS HAS EVER BEEN SHARED WITH ARJOHUNTLEIGH. BASING ON THE AVAILABLE LITERATURE REFERRING TO COMPRESSION SYSTEMS, INCLUDING SYNOPSES OF DVT OUTCOMES AND HEMODYNAMIC STUDIES, USING VARIOUS TYPES OF COMPRESSION AVAILABLE (CALF, THIGH AND/OR FOOT COMPRESSION), IT APPEARS POSSIBLE TO CONCLUDE THAT A PROLONGED SURGERY PROCEDURE AND/OR THE USE OF LITHOTOMY OR LLOYD DAVIES POSITION MAY BE CONSIDERED AS ONE THE FACTORS CONTRIBUTING TO THE COMPARTMENT SYNDROME DEVELOPMENT. NEVERTHELESS, WITHOUT THE SPECIFIC KNOWLEDGE ABOUT PATIENT'S MEDICAL CONDITION IT APPEARS IMPOSSIBLE TO DEFINE THE CAUSE OF COMPARTMENT SYNDROME DEVELOPED IN THE INVESTIGATED CASE. ANY COMPRESSION STOCKING USED SHOULD BE ROUTINELY CHECKED TO ENSURE CONTINUED PROPER FIT AND APPLICATION, IN ADDITION TO ASSESSING THE CONDITION OF THE SKIN. IT REMAINS UNKNOWN WHETHER A PROPER PROCEDURE OF PATIENT'S MONITORING WAS IMPLEMENTED DURING THE THERAPY. PATIENT'S OUTCOME WAS OBSERVED AFTER THE SURGERY WAS COMPLETED WHICH MAY INDICATE THE LACK OF RECOMMENDED FREQUENT SKIN INSPECTION THROUGHOUT THE PROCEDURE WHICH MIGHT HAVE ALLOWED TO NOTICE ABNORMAL SKIN CONDITION AT THE EARLIER STAGE AND STOP A COMPRESSION THERAPY AT THE TIME. TAKING INTO CONSIDERATION PREVIOUSLY REPORTED CASES OF ARJOHUNTLEIGH SYSTEMS INVOLVED COMPARTMENT SYNDROMES DEVELOPED AT PATIENT'S, THIS CONCLUSION SEEM TO BE IN LINE WITH REPORTED SCENARIOS - ALL OF THE EVENTS PRESENTED SCENARIOS OF A FEW-HOUR SURGERIES BEING PERFORMED SHORTLY BEFORE OR DURING THE EFFECT NOTICE. DESPITE OUR BEST EFFORTS IN GATHERING THE INFORMATION, THE EXACT ROOT CAUSE OF THE REPORTED INCIDENT CANNOT BE DETERMINED. IT HAS BEEN ESTABLISHED THAT THE FLOWTRON ACS900 PUMP WAS IN USE FOR A PATIENT THERAPY AT THE TIME OF THE EVENT. BASING ON THE LEVEL OF INFORMATION AVAILABLE TO DATE, THE PUMP WAS NOT FOUND TO HAVE MALFUNCTIONED (NOT PERFORMING UP TO SPECIFICATION) WHEN THE EVENT TOOK PLACE AND IT IS NOT BELIEVED TO HAVE CONTRIBUTED TO THE REPORTED PATIENT'S OUTCOME. WE ARE REPORTING THIS EVENT TO COMPETENT AUTHORITIES DUE TO A SERIOUS OUTCOME RECEIVED BY PATIENT.
ON (B)(6) 2016 ARJOHUNTLEIGH WAS INFORMED ABOUT AN INCIDENT WHICH OCCURED DURING USE OF FLOWTRON ACS900 COMBINED WITH A STANDARD CALF GARMENT L-501. IT WAS INDICATED THAT AN 18- OR 19-YEAR OLD PATIENT DEVELOPED A COMPARTMENT SYNDROME WHILE USING THE FLOWTRON SYSTEM AND REQUIRED A FASCIOTOMY PROCEDURE TO BE PERFORMED. IT WAS REPORTED THAT THE FLOWTRON SYSTEM WAS ISOLATED AND IS BEING EVALUATED BY THEIR BIOMED DEPT. THE PATIENT WAS UNDERGOING MAXILLOFACIAL SURGERY WHICH LASTED FOR 2 HOURS AND WAS PLACED IN THE SUPINE POSITION DURING THE PROCEDURE.
ARJOHUNTLEIGH HAS INVESTIGATED THE PROBLEM OF FLOWTRON ACS900 CONSTANT PRESSURE SINCE THE DATE OF THE FIRST INCIDENT OF THIS NATURE ((B)(6) 2016). DESPITE THE TESTING CONDUCTED, THE EXACT ROOT CAUSE OF THE PROBLEM COULD NOT HAVE BEEN DETERMINED AS THE FAILURE MODE COULD NOT HAVE BEEN DUPLICATED UNTIL THE LATER DATE. CONCLUSIONS OF ARJOHUNTLEIGH INVESTIGATION REMAINED UNCHANGED UNTIL ANOTHER INCIDENT OCCURRED ON (B)(6) 2017 IN THE USA. THIS WAS THE FIRST TIME ARJOHUNTLEIGH HAVE BEEN ABLE TO SEE AND TEST THE UNIT IN THE "FAILED" STATE, WHICH APPEARED TO BE AN INVESTIGATION MILESTONE. THE UNIT WAS LEFT CONNECTED TO MAINS POWER IN THE "FAILED" STATE, PERFORMANCE READINGS DIRECTLY OFF THE SYSTEM SUB-COMPONENTS STATE WERE COLLECTED FOR FURTHER ANALYSIS WHICH TOOK PLACE ON 3RD MAY, 2017. THE INVESTIGATION WAS DIVIDED INTO HARDWARE AND SOFTWARE POTENTIAL FAILURE AREAS WHICH WERE OBJECTS OF VERIFICATION. AT NO POINT DURING THIS INVESTIGATION WAS THE R&D TEAM ABLE TO REPLICATE THE ACTUAL FAILURE, ONLY FABRICATION OF THE FAILURE WAS ACHIEVED. THE DATA GATHERED DURING THE ACTIVITIES OF THE ON-SITE VISIT AIDED IN DETERMINING THAT THE FABRICATED FAILURE AND THE ACTUAL FAILURE STATE ARE VERY SIMILAR. THE ONLY DIFFERENCE BEING THAT IN THE ACTUAL FAILURE SERIAL COMMUNICATIONS WITH THE SYSTEM CONTROL CIRCUIT BOARD ARE NOT FUNCTIONAL, WHILE THEY ARE FUNCTIONAL DURING THE FABRICATED STATE. THIS INDICATED THAT THE SYSTEM WAS IN FACT IN THE SECONDARY STATE, WHICH IS ENTERED ONLY WHEN A SOFTWARE APPLICATION FAILURE IS DETECTED BY THE SYSTEM. INVESTIGATION COURSE REGARDING SOFTWARE AND HARDWARE SPECIFIC ISSUES DID NOT ALLOW DEFINING THE EXACT ROOT CAUSE OF THE OBSERVED FAILURE. THE INVESTIGATION HAS HOWEVER, WITH A HIGH DEGREE OF CONFIDENCE, SHOWN THAT SOFTWARE VERSION 2.000 WILL HANDLE THE FAILURE STATE IN A MORE RESILIENT MANNER WHEN STIMULATED BY ANY POTENTIAL CAUSE LEADING TO THE FAILURE STATE. IF THE FAILURE STATE OCCURS IN A DEVICE WITH SOFTWARE VERSION 2.000, THE DEVICE WILL RESET, RESTART, AND THERAPY WILL CONTINUE. THE SPECIFIC SYMPTOM OBSERVED IN THE FIELD MAY, WITH A HIGH DEGREE OF CONFIDENCE, BE ADDRESSED BY UPGRADING DEVICES TO SOFTWARE VERSION 2.000. ARJOHUNTLEIGH INITIATED A GLOBAL RECALL ON 01 JUN 2017 WITH AN (B)(4). POTENTIALLY AFFECTED PUMPS (SERIAL NUMBERS (B)(4)) ARE SUPPOSED TO BE CORRECTED IN THE FIELD VIA A SOFTWARE UPGRADE TO VERSION V2.000. THE APPROPRIATE COMMUNICATION TO CUSTOMERS IS BEING DISTRIBUTED. IT NEEDS TO BE EMPHASIZED THAT RESPONSIBLE CARE MUST BE TAKEN WHEN USING ANY PART OF A DEVICE THAT COMES INTO CONTACT WITH A PATIENT OR USER. PATIENT'S SKIN SHOULD BE INSPECTED FREQUENTLY DURING PROCEDURES AS PER THE INSTRUCTION FOR USE (526933EN). GARMENTS SHOULD BE REMOVED IMMEDIATELY IF THE PATIENT EXPERIENCES TINGLING, NUMBNESS OR PAIN. CLINICAL JUDGEMENT IS REQUIRED TO DETERMINE IF THE PATIENT'S SKIN CONDITION REQUIRES ADDITIONAL PROTECTIVE MEASURE OR IF THE THERAPY SHOULD BE DISCONTINUED AND AN ALTERNATIVE MODALITY USED. IN LIGHT OF THESE INFORMATION, LACK OF ACCURATE ASSESSMENT OF THE SKIN CONDITION IS CONSIDERED AS A CONTRIBUTING FACTOR. IT HAS BEEN ESTABLISHED THAT THE FLOWTRON ACS900 PUMP WAS USED FOR A PATIENT THERAPY AT THE TIME OF THE EVENT. THE SYSTEM HAS MALFUNCTIONED (DID NOT PERFORM TO SPECIFICATION) WHEN THE EVENT TOOK PLACE, THE PATIENT DEVELOPED A COMPARTMENT SYNDROME. IN RESPONSE TO THE LETTER RECEIVED ON 11TH MAY 2017, ARJOHUNTLEIGH WOULD LIKE TO INFORM THAT REQUESTED ADDITIONAL INFORMATION IS PROVIDED WITHIN THE ATTACHED RESPONSE LETTER AND FILES. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 10728 | FLOWTRON ACS 900 | SLEEVE, LIMB, COMPRESSIBLE | JOW | GETINGE (SUZHOU) CO., LTD. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 18 YR | Required Intervention |