BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACTIVECARE+SFT

    MDR report key: 4934431 · Received July 21, 2015

    Report

    Report Number
    9616558-2015-00001
    Event Type
    Death
    Date Received
    July 21, 2015
    Date of Event
    June 22, 2015
    Report Date
    June 23, 2015
    Manufacturer
    MEDICAL COMPRESSION SYSTEMS (DBN) LTD.
    Product Code
    JOW
    PMA / PMN Number
    K142728
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS FIRST ASSEMBLED I 10/2008. THE LAST MAINTENANCE AT THE COMPANY FACILITY WAS DONE IN 08/2014. THE UNIT WAS TESTED AND CLEANED BY THE LOCAL MCS REPRESENTATIVE PRIOR TO ISSUING THE DEVICE TO THE PT IN (B)(6) 2015. THERE IS NO INDICATION THAT THE ACTIVECARE+SFT DEVICE MALFUNCTION OR CONTRIBUTED TO PT'S DEATH.

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED AND COULD NOT BE EXAMINED, THEREFORE A ROOT CAUSE ANALYSIS COULD NOT BE CONDUCTED. EVALUATION OF DEVICE HISTORY RECORDS 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 MALFUNCTION OR CONTRIBUTED IN ANY WAY TO PATIENT'S DEATH. ATTEMPTS TO LOCATE THE DEVICE WERE UNSUCCESSFUL. FOLLOW UP WAS PERFORMED WITH THE AFTER CARE FACILITY ON (B)(6), WITH THE PATIENT'S FAMILY (VIA SURGEON) ON (B)(6), WITH THE HOSPITAL ER ON (B)(6), AND WITH THE HOSPITAL RISK MANAGEMENT OFFICE ON (B)(6). THE DEVICE TO DATE HAS NOT BEEN LOCATED. AS SUCH, FAILURE AND ROOT CAUSE ANALYSIS OF THE DEVICE IS NOT POSSIBLE. IF/WHEN THE DEVICE IS LOCATED AND RETURNED MCS WILL PERFORM INSPECTION AND ANALYSIS OF DEVICE. 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. REVIEW OF PATIENT RECORDS FROM THE AFTER CARE FACILITY INDICATE THE DEVICE WAS IN USE AND FUNCTIONING, INDICATING THE DEVICE WAS NOT MALFUNCTIONING. THE EMERGENCY ROOM PATIENT RECORDS ALSO INDICATE THAT THE PATIENT DIED FROM CARDIOPULMONARY ARREST. PERSONNEL IN THE OFFICE OF THE PHYSICIAN WHO SIGNED THE DEATH CERTIFICATE CONFIRMED THAT THE PHYSICIAN INDICATED CARDIOPULMONARY FAILURE AS CAUSE OF DEATH (CONVERSATION W/ MEDICAL ASST. FOR ATTENDING PHYSICIAN (B)(6)). MCS IS RESPONDING TO A LETTER OF INQUIRY FOR ADDITIONAL INFORMATION THAT IS DUE ON (B)(6) 2015 AND WILL SUBMIT THIS MDR TOGETHER WITH THAT DATA TO THE CDRH PRIOR TO (B)(6). MCS FAILURE MODE OF "NO FAILURE FOUND" WAS ASSIGNED AND MCS ROOT CAUSE CODE OF "NO FAILURE FOUND" AND "NOT CONFIRMED/NOT RETURNED" (SECONDARY) WERE ASSIGNED TO THIS COMPLAINT AS THERE IN ZERO INDICATION IN ANY OF THE PATIENTS MEDICAL RECORDS NOR IN ANY CONVERSATIONS WITH THE SURGERY AFTER CARE FACILITY, THE EMERGENCY ROOM PERSONNEL NOR THE EMERGENCY ROOM/HOSPITAL RISK MANAGEMENT THAT THE DEVICE HAD MALFUNCTIONED IN ANY WAY. THE NOTES FROM THE AFTER CARE FACILITY SIMPLY STATE THAT THE DEVICE HAD BEEN IN USE, IMPLYING THAT IT WAS FUNCTIONING AS INDICATED. THE NURSE WHO PRESENT WHEN THE DECEDENT STOPPED BREATHING WAS RE-INTERVIEWED AND CONFIRMED THAT THERE WERE NO WARNING LIGHTS OR ALARMS EMITTED FROM THE SFT DEVICE DURING THE INCIDENT. 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

    PT HAD TOTAL KNEE REPLACEMENT SURGERY ON (B)(6) 2015. HE WAS GIVEN TRANEXAMIC ACID DURING SURGERY TO REDUCE BLOOD LOSS. PER HIS SURGEON, THERE WERE NO COMPLICATIONS WITH THE SURGERY OR HIS RECOVERY AT THE (B)(6) HOSPITAL. THE PT WAS TRAINED TO USE THE ACTIVECARE+SFT DEVICE BEFORE DISCHARGE AND ADVISED TO TAKE ASPIRIN WHILE USING DEVICE FOR 14 DAYS. HE WAS TRANSFERRED TO A REHABILITATION CENTER ON (B)(6). PER HIS MEDICAL RECORDS FROM THE REHABILITATION CENTER, THE PT USED HIS ACTIVECARE+SFT DEVICE DAILY DURING THE DAY AND EVENING AND DID NOT EXPERIENCE ANY PROBLEM WITH THE DEVICE. HE WAS GIVEN ASPIRIN TWICE A DAY AND HAD NO COMPLICATIONS AND NO BREATHING PROBLEMS. ON (B)(6), THE LAST DAY OF HIS ACTIVECARE PRESCRIPTION, HE EXPERIENCED SHORTNESS OF BREATH AND STOPPED BREATHING WHEN RETURNING TO HIS BED FROM AN ASSISTED VISIT TO THE BATHROOM. THE NURSE ADMINISTERED CPR UNTIL THE 911 AMBULANCE ARRIVED. PT WAS TRANSPORTED TO THE HOSPITAL WHERE HE WAS PRONOUNCED DEAD. THE ACTIVECARE+SFT DEVICE WAS REPORTEDLY TRANSPORTED TO THE EMERGENCY ROOM WITH THE PT. ATTEMPTS TO LOCATE THE DEVICE HAVE BEEN UNSUCCESSFUL.

    Description of Event or Problem · 1

    NUMEROUS FOLLOW ATTEMPTS HAVE BEEN MADE TO GATHER ADDITIONAL INFORMATION REGARDING THE PATIENT STATUS LEADING UP TO THE INCIDENT AS WELL AS TO GATHER ADDITIONAL INFORMATION REGARDING THE CAUSE OF DEATH AND WHEREABOUTS OF THE DEVICE. FROM EMERGENCY ROOM RECORDS PREPARED BY THE ER PHYSICIAN: THE PATIENT HAD SHORTNESS OF BREATH AND THEN STOPPED BREATHING AT THE AFTERCARE FACILITY. CPR WAS INITIATED. PATIENT HAD NO PULSE AND WAS NOT BREATHING WHEN RESCUE SQUAD ARRIVED. HE WAS GIVEN CPR, PUT ON A BREATHING MASK AND GIVEN EPINEPHRINE TWICE IN ROUTE. HE WAS STILL IN CARDIAC ARREST UPON ARRIVAL AT 14:10 PM. THE ER UNIT CONTINUED TO TRY TO RESUSCITATE HIM. HE WAS PRONOUNCED DEAD AT 14:45 EDT. ATTENDING ER PHYSICIAN MADE A DIFFERENTIAL DIAGNOSIS OF CARDIOPULMONARY ARREST AND NOTED THAT HE HAD A FAMILY HISTORY OF STROKE AND MYOCARDIAL INFARCTION WITH PERSONAL RISK FACTORS OF SMOKING, HYPERTENSION AND RECENT SURGERY. REVIEW OF PATIENT RECORDS FROM THE AFTER CARE FACILITY INDICATE THE DEVICE WAS IN USE AND FUNCTIONING, INDICATING THE DEVICE WAS NOT MALFUNCTIONING. THE EMERGENCY ROOM PATIENT RECORDS ALSO INDICATE THAT THE PATIENT DIED FROM CARDIOPULMONARY ARREST. PERSONNEL IN THE OFFICE OF THE PHYSICIAN WHO SIGNED THE DEATH CERTIFICATE CONFIRMED THAT THE PHYSICIAN INDICATED CARDIOPULMONARY FAILURE AS CAUSE OF DEATH (CONVERSATION W/ (B)(6)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473324 ACTIVECARE+SFT COMPRESSIBLE LIMB SLEEVE JOW MEDICAL COMPRESSION SYSTEMS (DBN) LTD. ACTIVECARE+SFT NONE

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death