BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENASYS GO RENTAL DEVICE

    MDR report key: 3725016 · Received April 3, 2014

    Report

    Report Number
    3006760724-2014-00057
    Event Type
    Malfunction
    Date Received
    April 3, 2014
    Date of Event
    December 5, 2013
    Report Date
    April 2, 2014
    Manufacturer
    SMITH & NEPHEW WOUND MANAGEMENT
    Product Code
    BTA
    PMA / PMN Number
    K083375
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE PUMP WAS CONDUCTED BY (B)(4) ON 10 JANUARY 2014, NO ANOMALIES OR PROBLEMS WERE FOUND, THE PUMP PASSED ALL FUNCTIONAL TESTS (REFERENCE APPENDIX 4, VER 2:WI020 RQ-05 [UM01071] REV N JOB# SNWT (B)(4)) LOSS OF DRESSING ADHESION COULD BE ATTRIBUTED TO A COMBINATION OF FACTORS SUCH AS WOUND LOCATION, PATIENT MOBILITY, CONSTANT FRICTION, PRESSURE DIRECTLY APPLIED TO WOUND SITE, ACCUMULATION OF MOISTURE UNDERNEATH THE DRESSING, AND PROPER PREPARATION OF THE PERIWOUND SKIN AS PER CLINICAL GUIDELINES. IN REGARDS TO A PUMP NOT TRIGGERING A LEAK ALARM, THE MOST PROBABLE CAUSE WAS THAT THE SYSTEM WAS MAINTAINING NEGATIVE PRESSURE AS A RESULT OF A PARTIAL BLOCKAGE AND A LEAK NOT SIGNIFICANT ENOUGH IN ORDER TO TRIGGER AN ALARM. TYPICALLY, PARTIAL BLOCKAGES ARE CAUSED BY CLOTTING AT THE HEAD OF THE SOFT PORT OR BUILDUP OF BLOOD CLOTS/EXUDATE INSIDE THE WOUND FILLER (GAUZE) AND/OR THE SOFT PORT FLUID HANDLING PATHWAY. THIS COMPLAINT IS CONSIDERED INCONCLUSIVE. SINCE THE NPWT INVOLVES VARIOUS ELEMENTS, IT IS DIFFICULT TO DETERMINE AND ASSIGN AN EXACT ROOT CAUSE FOR THE ISSUE REPORTED. THE ROOT CAUSE FOR THE REPORTED ISSUE IS DEEMED UNDETERMINED. IN RESPONSE TO SIMILAR COMPLAINTS, SMITH & NEPHEW HAS ISSUED CAR02714 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.

    Additional Manufacturer Narrative · 1

    ACTIVE INVESTIGATION IN-PROGRESS, RESULTS OF THE INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENT REPORT. AS A RESULT OF 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. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED BY SMITH & NEPHEW AS A RESULT OF A RETROSPECTIVE REVIEW OF COMPLAINTS, INCLUDING ADVERSE EVENTS, AS PART OF CORRECTIVE AND REMEDIATION ACTIONS FOLLOWING THE ISSUANCE OF THE (B)(4) ISSUED (B)(4) 2013 TO SMITH & NEPHEW, INC. FEI NO: (B)(4). SMITH & NEPHEW IS PERFORMING A TWO-YEAR RETROSPECTIVE REVIEW OF COMPLAINT FILES TO RE-ASSESS REPORTABILITY CRITERIA AND REPORTING DECISIONS MADE FOR COMPLAINTS RECORDED DURING THE TIME PERIOD UNDER REVIEW. THIS COMPLAINT HAS BEEN RE-ASSESSED IN ACCORDANCE UNDER THE PROVISIONS OF 21CFR 803.50 AND DEEMED REPORTABLE AS AN MDR. WE ARE SUBMITTING ONE (1) INITIAL, 30 DAY REPORT, MEDWATCH FDA FORM 3500A, FOR A PURPORTED DEVICE MALFUNCTION WHICH OCCURRED WHILE USING THE RENASYS EZ.

    Description of Event or Problem · 1

    FAILURE TO ALARM: DRESSING CAME LOOSE BUT DID NOT ALARM.

    Description of Event or Problem · 1

    FAILURE TO ALARM: DRESSING CAME LOOSE BUT DID NOT ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202906 RENASYS GO RENTAL DEVICE PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED) BTA SMITH & NEPHEW WOUND MANAGEMENT 66800164R KGUA120151

    Patients

    Seq Age Sex Outcome Treatment
    1 Other