BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACTIVECARE+SFT

    MDR report key: 5224491 · Received November 15, 2015

    Report

    Report Number
    9616558-2015-00002
    Event Type
    Death
    Date Received
    November 15, 2015
    Date of Event
    October 5, 2015
    Report Date
    October 13, 2015
    Manufacturer
    MEDICAL COMPRESSION SYSTEMS DBN LTD.
    Product Code
    JOW
    PMA / PMN Number
    K151377
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE RETURNED, VISUALLY INSPECTED AND TESTED PER INTERNAL TEST AND INSPECTION PROTOCOLS. EVALUATION OF DEVICE HISTORY RECORDS, DEVICE USAGE AND USAGE COMPLIANCE HISTORY WAS PERFORMED AS WELL AS EVALUATION OF THE PATIENT MEDICAL RECORDS WAS PERFORMED. THERE ARE NO INDICATIONS THAT THE ACTIVECARE+SFT DEVICE THAT WAS IN-USE BY THE PATIENT HAD MALFUNCTIONED OR CONTRIBUTED IN ANY WAY TO PATIENT'S DEATH. FOLLOW UP WAS PERFORMED AND CONFIRMED THAT THERE WERE NO REPORTS OF DEVICE PROBLEMS. INSPECTION/TESTING RESULTS REVEAL THAT THE DEVICE WAS IN NORMAL FUNCTIONAL ORDER AND THAT THERE WERE NO ANOMALY'S. ADDITIONALLY, REVIEW OF THE SPECIFIC DEVICE HISTORY RECORDS (DHR) INDICATE THAT THE DEVICE WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND PASSED ALL IN-PROCESS AND FINAL INSPECTIONS PRIOR TO RELEASE FOR DISTRIBUTION. THE DHR HAD NO INDICATIONS OF NON-CONFORMANCE DURING MANUFACTURE. DEVICE COMPLIANCE DATA WAS EXAMINED (COMPLIANCE = USE OF DEVICE BY THE PATIENT). DATA SHOWS 84% COMPLIANCE WITH USE OF DEVICE, WITH THE FOLLOWING DAILY COMPLIANCE: 98.8%, 83.2%, 94.2%, 61.7%, 78.6%. THE DAILY COMPLIANCE ON THE FOLLOWING DAYS IS ZERO, INDICATING THE PATIENT USED THE DEVICE ONLY FOR 5 DAYS, WHICH IS CONSISTENT WITH THE PRESCRIPTION. DEATH CERTIFICATE STATES "PROBABLE PULMONARY EMBOLISM" SECONDARY TO "TOTAL HIP REPLACEMENT" SURGERY. MCS FAILURE MODE OF "NO FAILURE FOUND" WAS ASSIGNED AND MCS ROOT CAUSE CODE OF "NO FAILURE FOUND" WERE ASSIGNED TO THIS COMPLAINT AS THERE IN ZERO INDICATION IN ANY OF THE PATIENTS MEDICAL RECORDS NOR IN ANY CONVERSATIONS WITH THE SURGERY STAFF OR PRIMARY CARE STAFF THAT THE DEVICE HAD MALFUNCTIONED IN ANY WAY. BASED ON THE ABOVE COMMENTS WE HAVE COME TO THE CONCLUSION THAT THERE WAS NO DEVICE MALFUNCTION AND IT DID NOT CONTRIBUTE TO THE PATIENT OUTCOME (DEATH).

    Description of Event or Problem · 1

    (B)(6) MORBIDLY OBESE FEMALE WITH END STAGE OSTEOARTHRITIS IN LEFT HIP HAD LEFT TOTAL HIP REPLACEMENT ON (B)(6) 2015. THE PATIENT WAS TREATED WITH KEFZOL 3 GRAMS IV ON CALL TO THE OPERATING ROOM AND 2 GRAMS IV Q8H FOR 24 HOURS POST-OP. THE PATIENT WAS STARTED ON ASPIRIN 325 MG P/O BID THE DAY AFTER SURGERY WITH SEQUENTIAL COMPRESSION DEVICES FOR PHLEBITIS PROPHYLAXIS AND THIS WAS TO CONTINUE FOR 5 DAYS POST OPERATIVELY. THE PATIENT STARTED RANGE OF MOTION EXERCISES ON THE FIRST DAY OF THE SURGERY AND WAS DISCHARGED WHEN THE PAIN WAS CONTROLLED WITH ORAL PAIN MEDICATION WITH PLANS FOR FOLLOW UP IN ONE MONTH. DISCHARGE MEDICATIONS INCLUDE ASPIRIN 325 PO BID WITH SEQUENTIAL COMPRESSION DEVICES. PERCOCET 10/325, 1 TO 2 TABLETS BY MOUTH (TOTAL OF 75 TABLETS NO REFILLS). THE REMAINDER OF HER MEDICATIONS WOULD BE THE SAME AS HER ADMISSION MEDICATIONS: CELEBREX 200 MG PO DAILY, EFFEXOR 75MG PO DAILY, LISINOPRIL 10MG PO QAM, NEURONTIN 300MG PO BID, TIZANIDINE 4MG PO TID, AND FLUOCINONIDE 0.05 PERCENT CREAM TOPICALLY AS NEEDED FOR ECZEMA. KEEP WOUND COVERED, CLEAN AND DRY UNTIL STAPLE REMOVAL SCHEDULED FOR 2 WEEKS FROM TIME OF SURGERY. PER MEDICAL RECORD, THERE WERE NO COMPLICATIONS. ON (B)(6) 2015 THE PATIENT PASSED AWAY IN HER PRIVATE RESIDENCE. FOLLOW UP FOR ADDITIONAL INFORMATION WAS PERFORMED WITH PERSONNEL FROM BOTH THE MEDICAL EQUIPMENT PROVIDER (PROVIDER OF THE ACTIVECARE DEVICE) AND THE PATIENT'S PRIMARY CARE PHYSICIAN'S OFFICE; ACQUIRED ADDITIONAL INFORMATION FOLLOWS: NO AUTOPSY WAS PERFORMED SO THE EXACT CAUSE OF DEATH IS NOT KNOWN. THE DEATH CERTIFICATE AND MEDICAL RECORDS FOR THE PATIENT RECENT HISTORY WERE REQUESTED FROM THE PATIENT'S PRIMARY CARE OFFICE AND WERE PROVIDED. THE CAUSE OF DEATH ON THE DEATH CERTIFICATE IS STATES AS "PROBABLE PULMONARY EMBOLISM" SECONDARY TO "LEFT HIP REPLACEMENT". ADDITIONAL FOLLOW UP WITH MEDICAL EQUIPMENT PROVIDER PROVIDED INFORMATION CONSISTENT WITH THAT STATED ABOVE, INCLUDING REPORT THAT TO THE BEST OF THEIR KNOWLEDGE THE DEVICE WAS USED UP UNTIL THE DATE THE PATIENT DIED. NO ONE WITNESSED THE PATIENT PASSING AND THERE WAS NO NEED FOR ADMITTANCE TO A HOSPITAL. NEITHER SOURCE OF ADDITIONAL INFORMATION RECEIVED REPORTS THAT THE COMPRESSION DEVICE (ACTIVECARE +SFT) WAS MALFUNCTIONING, NO REPORTS FROM PATIENT OF DEVICE NOT WORKING. THE PATIENT NEVER CALLED TO DISCUSS ANY ISSUES WITH THE ACTIVE CARE DEVICE. ALL INDICATIONS FROM FOLLOW UP INDICATE THAT THE DEVICE WAS FUNCTIONING NORMALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    754340 ACTIVECARE+SFT COMPRESSIBLE LIMB SLEEVE JOW MEDICAL COMPRESSION SYSTEMS DBN LTD. ACTIVECARE+SFT NA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death