BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENASYS SOFT PORT STAND ALONE

    MDR report key: 3771201 · Received April 24, 2014

    Report

    Report Number
    3006760724-2014-00315
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    January 18, 2013
    Report Date
    April 24, 2014
    Manufacturer
    SMITH & NEPHEW WOUND MANAGEMENT
    Product Code
    BTA
    PMA / PMN Number
    K110647
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A LOT NUMBER WAS NOT PROVIDED, AS PART OF THE REPORTED COMPLAINT. A DHR REVIEW COULD NOT BE PERFORMED WITH THE LIMITED INFORMATION PROVIDED. A PHOTO WAS PROVIDED BY THE CUSTOMER AS PART OF THE REPORTED COMPLAINT. THE COMPLAINT INDICATES A PATIENT WITH TWO SOFT PORT Y CONNECTED TO ONE WOUND WITH PARTIAL BRIDGING AND ATTACHED TO A RENASYS EZ. BOTH SOFT PORT WERE SOFT AND LIFTED AND THERE WAS NO LEAK ALARM. UPON THE EVALUATION OF THE PHOTOS PROVIDED, IT IS EVIDENT THAT THE SYSTEM WAS COLLECTING EXUDATE IN THE CANISTER. THE PUMP WAS SET UP TO 80MMHG. IT WAS REPORTED WITHIN THE COMPLAINT THAT THERE WAS NO PROBLEM WITH THE DEVICE. IF DRESSINGS ARE NOT VISIBLY COMPRESSED, AND NO LEAK ALARM HAS SOUNDED IT IS MOST LIKELY THAT A BLOCKAGE WITHIN THE FLUID HANDLING PATHWAY IS PRESENTED. THE SYSTEM WAS HOLDING THE NEGATIVE PRESSURE PROBABLY AS A RESULT OF THE BLOCKAGE AND A LEAK NOT SIGNIFICANT ENOUGH IN ORDER TO TRIGGER AN ALARM. THE PUMP OPERATES NORMALLY FOR LEAK RATES UP TO A RANGE OF 2.5 -3.5 L/MIN BUT IS DESIGNED TO ALARM FOR EXCESSIVE LEAK FOR MORE THAN 3 MINUTES, THEREFORE NOT INSTANTANEOUS. THERE IS NO INFORMATION WITHIN THE REPORT FOR HOW LONG BOTH SOFT PORT WERE LIFTED FROM THE WOUND AREA. IT IS CLEARLY SHOW IN THE PICTURE PROVIDED BY THE CUSTOMER THAT THE SYSTEM WAS HOLDING THE NEGATIVE PRESSURE. THE COMPLAINT IS DEEMED INCONCLUSIVE. 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 483 ISSUED NOVEMBER 26, 2013 TO SMITH & NEPHEW, INC. (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 SMALL NPWT FOAM FILLER KIT.

    Description of Event or Problem · 1

    FAILURE TO ALARM; PATIENT HAD TWO SOFT PORTS Y CONNECTED TO ONE WOUND WITH PARTIAL BRIDGING AND ATTACHED A RENASYS EZ PUMP. THE CLINICIAN ASSESSED THE WOUND AND BOTH SOFT PORTS WERE SOFT AND LIFTED AND THERE WAS NOT LEAK ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250199 RENASYS SOFT PORT STAND ALONE PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED) BTA SMITH & NEPHEW WOUND MANAGEMENT 66800799

    Patients

    Seq Age Sex Outcome Treatment
    1