BEUDAMED
    FDA Adverse Event Death Summary report: N

    RENASYS AB DRSG KIT W SOFTPORT

    MDR report key: 3745760 · Received April 11, 2014

    Report

    Report Number
    3006760724-2014-00082
    Event Type
    Death
    Date Received
    April 11, 2014
    Date of Event
    March 2, 2014
    Report Date
    July 7, 2014
    Manufacturer
    SMITH & NEPHEW WOUND MANAGEMENT
    Product Code
    BTA
    PMA / PMN Number
    K100787
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACTIVE INVESTIGATION IN PROGRESS; RESULTS OF INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENT REPORT. ALTHOUGH THE PATIENT DEATH IS NOT BEING ATTRIBUTED TO THE SMITH & NEPHEW DEVICE AT THIS TIME, IN RESPONSE TO SIMILAR COMPLAINTS, SMITH & NEPHEW HAS ISSUED (B)(4) TO INITIATE RENASYS PRODUCT LABELING UPDATES. THESE LABELLING UPDATES WILL PROVIDE ENHANCED INFORMATION ON THE FUNCTIONALITY OF THE ALARMS AS THEY RELATE TO THE DESIGN OF THE DEVICE, AND SCENARIOS THAT CAN OCCUR IN CLINICAL SETTINGS WHICH MAY IMPACT ALARM FUNCTIONALITY. NO OTHER COMPLAINTS HAVE BEEN RECEIVED FOR THIS LOT NUMBER.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT IS INCONCLUSIVE SINCE THE CIRCUMSTANCE CANNOT BE DUPLICATED AND NO PRODUCT WAS RETURNED FOR EVALUATION. SINCE NEGATIVE PRESSURE THERAPY INVOLVES VARIOUS ELEMENTS WITHIN A SYSTEM (I.E. PUMP, CANISTER, SUCTION PORT ETC.), IT IS DIFFICULT TO DETERMINE A DEFINITIVE ROOT CAUSE FOR THE FAILURE TO ALARM. IT IS POSSIBLE THAT THE ALARM DID NOT TRIGGER BECAUSE THE PUMP RECEIVED ENOUGH OF A FLOW RATE OF AIR TO PREVENT A BLOCKAGE OR LEAK ALARM FROM SOUNDING. IT CANNOT BE DETERMINED FROM THE COMPLAINT DESCRIPTION WHAT THE CONDITIONS WERE WITHIN THE SYSTEM AND THEREFORE A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THERE IS NO SPECIFIC INFORMATION ABOUT PRESSURE SETTINGS USED TO MANAGE THE ABDOMINAL FLUID. WITHOUT THIS INFORMATION, WE ARE UNABLE TO DETERMINE IF THE PRESSURE SETTINGS WERE WITHIN THE RECOMMENDED SETTINGS ACCORDING TO IFU. ATTEMPTS WERE MADE TO GATHER ADDITIONAL INFORMATION FROM THE CUSTOMER. PER THE RESPONSE RECEIVED, THE CLINICIAN INVOLVED WAS PLACED ON LEAVE AND NO ADDITIONAL INFORMATION WAS AVAILABLE. IN ADDITION, THE IFU INSTRUCTS TO MONITOR THE PATIENT CONDITION EVERY 4 HOURS OR AS NEEDED. HOWEVER, THE COMPLAINT DETAILS THAT THE NURSE FOUND THE DRESSING DRIED OUT WITH THE PATIENT¿S BED WET ON THE FOLLOWING MORNING AFTER DRESSING APPLICATION. THIS SUGGESTS AN INADEQUATE LEVEL OF KNOWLEDGE OF THE CLINICAL TEAM. ACCORDING TO THE MEDICAL ASSESSMENT, INSPECTION OF THE DRESSING IN A TIMELY MANNER WOULD HAVE MADE APPARENT ANY INADEQUACY IN THE APPLICATION OF THE DRESSING, OCCLUSION OF THE DRESSING LAYER OR OTHER TECHNICAL ISSUES AND LED TO CORRECTIVE ACTION. IN RESPONSE TO FAILURE TO ALARM COMPLAINTS, SMITH & NEPHEW HAS ISSUED A CORRECTIVE ACTION TO INITIATE RENASYS PRODUCT LABELING UPDATES. THESE LABELLING UPDATES WILL PROVIDE ENHANCED INFORMATION ON THE FUNCTIONALITY OF THE ALARMS AS THEY RELATE TO THE DESIGN OF THE DEVICE, AND SCENARIOS THAT CAN OCCUR IN CLINICAL SETTINGS WHICH MAY IMPACT ALARM FUNCTIONALITY. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED BECAUSE NO LOT INFORMATION WAS RECEIVED. COMPLAINTS WILL CONTINUE TO BE MONITORED.

    Description of Event or Problem · 1

    A PATIENT WENT INTO SURGERY FOR ABDOMINAL COMPARTMENT SYNDROME AND HAD THE RENASYS EZ MAX PLACED WITH OUR ABDOMINAL KIT FOR AN OPEN ABDOMEN. THE WOUND CARE NURSE REPORTED THAT SHE FOUND THE DRESSING WITH THE SIDES ROLLED UP AND THE FOAM/DRESSING NON-COMPRESSED THE FOLLOWING DAY AND SHE REPORTED TO US THAT THE PUMP ¿NEVER ALARMED ALL NIGHT.¿ ADDITIONALLY, SHE REPORTED THAT THE ORGAN PROTECTIVE LAYER WAS ¿DRIED OUT.¿ SHE TOLD S&N THAT THERE WAS MINIMAL DRAINAGE IN THE CANISTER BUT THAT THE PATIENT¿S BED WAS WET. THE PATIENT WAS TAKEN BACK TO SURGERY THE FOLLOWING DAY. IT WAS NOT STATED IF THE NEED FOR SURGERY WAS RELATED TO OUR NPWT SYSTEM. THE PATIENT EXPIRED DURING SURGERY ¿ IT WAS NOT STATED BY THE WOUND CARE TEAM IF THE CAUSE OF DEATH WAS RELATED TO OUR NPWT SYSTEM.

    Description of Event or Problem · 1

    A PATIENT WENT INTO SURGERY FOR ABDOMINAL COMPARTMENT SYNDROME AND HAD THE RENASYS EZ MAX PLACED WITH OUR ABDOMINAL KIT FOR AN OPEN ABDOMEN. THE WOUND CARE NURSE REPORTED THAT SHE FOUND THE DRESSING WITH THE SIDES ROLLED UP AND THE FOAM/DRESSING NON-COMPRESSED THE FOLLOWING DAY AND SHE REPORTED TO US THAT THE PUMP ¿NEVER ALARMED ALL NIGHT.¿ ADDITIONALLY, SHE REPORTED THAT THE ORGAN PROTECTIVE LAYER WAS ¿DRIED OUT.¿ SHE TOLD S&N THAT THERE WAS MINIMAL DRAINAGE IN THE CANISTER BUT THAT THE PATIENT¿S BED WAS WET. THE PATIENT WAS TAKEN BACK TO SURGERY THE FOLLOWING DAY. IT WAS NOT STATED IF THE NEED FOR SURGERY WAS RELATED TO OUR NPWT SYSTEM. THE PATIENT EXPIRED DURING SURGERY. SMITH & NEPHEW REPRESENTATIVE MET WITH THE WOUND CARE TEAM AND WAS ABLE TO GATHER THE FOLLOWING ADDITIONAL DETAILS ABOUT THE INCIDENT: AFTER THE WOUND CARE TEAM FOUND AND RESOLVED THE LEAKING DRESSING, THE PATIENT WAS TAKEN BACK TO THE OR BY DR. [REDACTED] WHERE HE SUCCESSFULLY CLOSED THE PATIENT. THE PATIENT WAS THEN TAKEN BACK TO THE CVICU WHERE HE EXPIRED SEVERAL HOURS LATER. PER THE WOUND CARE NURSES, THE SMITH & NEPHEW NPWT SYSTEM IS NOT BEING IMPLICATED IN THE PATIENT'S DEATH AT THIS TIME, HOWEVER INTERNAL INCIDENT REPORTS HAVE BEEN FILED BY THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225608 RENASYS AB DRSG KIT W SOFTPORT RENASYS AB DRSG KIT W SOFTPORT BTA SMITH & NEPHEW WOUND MANAGEMENT 66800980

    Patients

    Seq Age Sex Outcome Treatment
    1 Death