BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENASYS GO NEGATIVE PRESSURE WOUND THERAPY

    MDR report key: 3646871 · Received February 26, 2014

    Report

    Report Number
    3006760724-2014-00020
    Event Type
    Malfunction
    Date Received
    February 26, 2014
    Date of Event
    January 15, 2014
    Report Date
    May 7, 2014
    Manufacturer
    SMITH & NEPHEW WOUND MANAGEMENT
    Product Code
    BTA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS CONSIDERED INCONCLUSIVE. A TECHNICAL EVALUATION CONDUCTED AT THE (B)(4) SERVICE CENTER ON 11 MARCH 2014 DID NOT FIND ANY DEFECT THAT COULD HAVE CONTRIBUTED TO THE REPORTED FAILURE TO ALARM ISSUE. THE PUMP WAS FOUND WITH COSMETIC DAMAGES (ODOR AND BROKEN TOP CASE AND DOOR FLAP) AND POWER UP FAILURE (CODE 31) REQUIRING RESETTING TO PROPERLY TURN ON THE DEVICE, HOWEVER, AFTER RESETTING, THE PUMP PASSED ALL FUNCTIONAL TESTS AND FOUND WORKING WITHIN SPECIFICATION(REFER TO RA#203753-007). SINCE NEGATIVE PRESSURE WOUND THERAPY 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. MOST LIKELY A PARTIAL BLOCKAGE CAUSED BY CLOTTING AT THE HEAD OF THE SOFT PORT OR GRADUAL BUILDUP OF BLOOD CLOTS/EXUDATE INSIDE THE SOFT PORT FLUID HANDLING PATHWAY LED TO THE OBSERVED ISSUE (PUMP NOT ALARMING AND DRESSING FALLING OFF). IT IS VERY LIKELY THE PUMP DID NOT ALARM BECAUSE THE SYSTEM WAS STILL REACHING VACUUM IN PRESENCE OF PARTIAL BLOCKAGE AND A LEAK NOT SIGNIFICANT ENOUGH TO TRIGGER AN ALARM. IN ORDER FOR THE BLOCKAGE ALARM TO BE TRIGGERED, THE FLUID HANDLING PATHWAY MUST BE ¿FULLY¿ OCCLUDED, IF A ¿PARTIAL¿ BLOCKAGE OCCURRED AT THE WOUND SITE OR WITHIN THE FLUID HANDLING PATHWAY AND AIR WAS STILL REACHING THE SYSTEM, THE PUMP WOULD NOT ALARM. IN REGARDS TO THE LEAK ALARM, THE SYSTEM IS DESIGNED TO ASSERT A LEAK ALARM WHEN THE FLUID HAS CLEARED THE TUBING SET AND AIR HAS BEEN FREELY FLOWING THROUGH THE TUBING IN A RATE GREATER THAN 3.5L/MIN. IN RESPONSE TO FAILURE TO ALARM 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

    ADDITIONAL INVESTIGATION IN-PROGRESS, RESULTS OF THE INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENT REPORT.

    Description of Event or Problem · 1

    FAILURE TO ALARM: PUMP NOT ALARMING AND THE DRESSING FELL OFF.

    Description of Event or Problem · 1

    FAILURE TO ALRM: PUMP NOT ALARMING AND THE DRESSING FELL OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118215 RENASYS GO NEGATIVE PRESSURE WOUND THERAPY RENASYS GO RENTAL DEVICE BTA SMITH & NEPHEW WOUND MANAGEMENT 66800164R KGUC120377

    Patients

    Seq Age Sex Outcome Treatment
    1 Other