BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENASYS GO

    MDR report key: 10015883 · Received April 30, 2020

    Report

    Report Number
    8043484-2020-00353
    Event Type
    Malfunction
    Date Received
    April 30, 2020
    Date of Event
    April 5, 2020
    Report Date
    August 14, 2020
    Manufacturer
    SMITH & NEPHEW MEDICAL LTD.
    Product Code
    OMP
    PMA / PMN Number
    K152163
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE, USED IN TREATMENT, HAS NOT BEEN RETURNED FOR EVALUATION. VISUAL INSPECTION AND FUNCTIONAL EVALUATION COULD NOT BE PERFORMED. WE HAVE BEEN UNABLE TO CONFIRM A RELATIONSHIP BETWEEN THE EVENT AND THE DEVICE OR IDENTIFY A ROOT CAUSE ON THIS OCCASION. IF THE DEVICE IS RETURNED IN THE FUTURE THIS COMPLAINT WILL BE RE-ASSESSED. SUCTION FAILURE: THIS SITUATION COULD OCCUR WHEN THERE IS MISALIGNMENT OR A PHYSICAL BLOCKAGE AT THE SOFTPORT TO DRESSING INTERFACE. IT IS POSSIBLE IN CERTAIN SITUATIONS SUCTION FAILURE CAN ALSO OCCUR AS A RESULT OF AN INSUFFICIENT SEAL ON THE DRESSING. THE IFU HAS BEEN REVIEWED WHICH CONTAINS ADEQUATE STEPS AND GUIDANCE WITH REGARDS TO ISSUES WITH SUCTION FAILURE. A REVIEW OF THE DEVICE HISTORY FOR THE DEVICE SHOWED THAT IT PASSED ALL ACCEPTANCE CRITERIA AND WAS COMPLIANT UPON RELEASE FOR DISTRIBUTION. THERE WERE NO INDICATIONS TO SUGGEST THE DEVICE DID NOT MEET PRODUCT SPECIFICATIONS NOR DID IT ALLEGE ANY PRODUCT DEFICIENCIES. COMPLAINT HISTORY REVIEWED HAS REVEALED FURTHER INSTANCES, THESE INSTANCES ARE BEING MONITORED TO DETERMINE IF ADDITIONAL ACTIONS ARE REQUIRED. CLINICAL INVESTIGATION CONCLUDED, THERE WAS NO HARM OR INJURY TO THE PATIENT REPORTED. THEREFORE, NO FURTHER CLINICAL/MEDICAL ASSESSMENT IS WARRANTED AT THIS TIME. SHOULD ANY ADDITIONAL MEDICAL INFORMATION BE PROVIDED THIS COMPLAINT WILL BE RE-ASSESSED. RISK MANAGEMENT REVIEW CONCLUDED THAT THE FILE CONTAINS MULTIPLE REASONS FOR DIFFICULTY IN CREATING A VACUUM INCLUDING DIFFICULTY IN SEALING DRESSINGS, DAMAGED COMPONENTS, MISSING COMPONENTS AND FAULTY PRESSURE MONITOR. WITHOUT FURTHER INFORMATION OR A RETURNED DEVICE INSPECTION, AN ACCURATE FAILURE MODE CANNOT BE ASCERTAINED. NO FURTHER ACTIONS BY SMITH AND NEPHEW ARE DEEMED NECESSARY AT THIS STAGE. HOWEVER, WE WILL CONTINUE TO MONITOR FOR ANY ADVERSE TRENDS RELATING TO THIS PRODUCT RANGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CALL RECEIVED FROM THE HOSPITAL STATED THAT DURING AN OPERATION THE DEVICE DID NOT CREATE SUCTION. THE CANISTER WAS CHANGED, A DIFFERENT DEVICE USED AND THE SOFTPORT WAS ALSO REPLACED. THE CANISTERS ALL HAD THE SAME LOT NUMBER AND THE PROBLEM CONTINUED. AFTER A CANISTER WITH A DIFFERENT LOT NUMBER WAS CONNECTED TO A UNIT, A SUCTION WAS BUILT UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479292 RENASYS GO NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP OMP SMITH & NEPHEW MEDICAL LTD. KHCK180987

    Patients

    Seq Age Sex Outcome Treatment
    1 CANISTER 300ML, PART: 66800914, LOT: D1907915