BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL NPWT FOAM FILLER KIT

    MDR report key: 3771235 · Received April 24, 2014

    Report

    Report Number
    3006760724-2014-00316
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    May 3, 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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE AND/OR PHOTO WERE PROVIDED FOR EVALUATION. A BATCH RECORD REVIEW WAS CONDUCTED, AND NO ISSUE WAS DETECTED THAT COULD LEAD TO THE FAILURE REPORTED WITHIN THE COMPLAINT. THE PRODUCT WAS MANUFACTURED ACCORDINGLY TO THE SPECIFICATIONS. THERE IS NO INDICATION WITHIN THE REPORT OF THE TIME ELAPSED BETWEEN DRESSING CHANGES, IF THERE WAS EXUDATE AT THE CANISTER AND THE POSITION OF THE DEVICE IN RELATION WITH THE WOUND LOCATION. AS PART OF THE IFU, IT IS RECOMMENDED TO CHANGE THE DRESSING EVERY 48 HOURS AND ENSURE THAT ALL PIECES OF FOAM ARE REMOVED FROM THE WOUND. IN ADDITION, THE IFU INCLUDES THAT IN THE EVENT OF HEAVY DRAINAGE MORE FREQUENT DRESSING CHANGES MAY BE REQUIRED. THE DEVICE NEEDS TO BE IN A VERTICAL POSITION DURING USE. THE PUMP DIDN'T ALARM BECAUSE THE SYSTEM WAS HOLDING THE NEGATIVE PRESSURE PROBABLY AS A RESULT OF A BLOCKAGE, CAUSED BY CLOTTING AT THE HEAD, OR GRADUAL BLOCKAGE/BUILDUP OF BLOOD CLOTS/EXUDATE INSIDE THE SOFT PORT FLUID HANDLING PATHWAY, JOINED WITH A LEAK NOT SIGNIFICANT ENOUGH IN OTHER TO TRIGGER AN ALARM. IT IS CLEARLY STATED WITHIN THE REPORT THAT THE DEVICE WAS RUNNING NORMALLY, CONFIRMING THAT THE SYSTEM WAS WORKING WITHIN SPECIFICATIONS. THE COMPLAINT IS DEEMED UNCONFIRMED. THERE IS INDICATED WITHIN THE REPORT THAT PROBABLY THE SOFT PORT WAS CLOGGED AND THE ISSUE WAS RESOLVED ONCE THE SOFT PORT WAS CHANGED. 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. 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 VERSAJET II EXACT 45DEG X 14MM.

    Description of Event or Problem · 1

    THE SOFT PORT DID NOT TAKE A NEGATIVE PRESSURE AT ALL THOUGH THE PUMP DID RUN NORMALLY (NO ALARM DID SOUND). THE CUSTOMER DID REPLACE THE SOFT PORT WITH NEW ONE, WHICH WAS USED WITHOUT PROBLEM. THEN THEY SUSPECTED THE SOFT PORT CLOGGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249904 SMALL NPWT FOAM FILLER KIT PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED) BTA SMITH & NEPHEW WOUND MANAGEMENT 66801088 2012100403

    Patients

    Seq Age Sex Outcome Treatment
    1