BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PICO SINGLE USE NEGATIVE PRESSURE WOUND THERAPY SYSTEM

    MDR report key: 3758641 · Received April 18, 2014

    Report

    Report Number
    3006760724-2014-00148
    Event Type
    Malfunction
    Date Received
    April 18, 2014
    Date of Event
    July 26, 2012
    Report Date
    April 16, 2014
    Manufacturer
    SMITH & NEPHEW WOUND MANAGEMENT
    Product Code
    BTA
    PMA / PMN Number
    K111170
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 PICO SINGLE USE NEGATIVE PRESSURE WOUND THERAPY SYSTEM. SMITH & NEPHEW RECEIVED THE ABOVE NAMED PRODUCT REPORTED AS A FIELD COMPLAINT FOR STOPPED WORKING. THE COMPLAINT REPORTED A PICO PUMP HAD CEASED WORKING BEFORE SEVEN DAY LIFE TIME HAD BEEN REACHED. IT SHOULD BE NOTED THAT WHENEVER THE BATTERIES ARE IN THE DEVICE (WHETHER SWITCHED ON OR NOT) THE 7 DAY TIMER IS ACTIVATED. THE PUMPS ARE 100% TESTED IN ACCORDANCE WITH OUR QUALITY CONTROL PROCEDURES AS FOLLOWS: CHECK PUMP POWERS ON; INSPECT BATTERY COMPARTMENT, ENSURING BATTERY CONTACTS ARE UNDAMAGED; ENSURE THERE ARE NO LEAKS WITHIN THE SYSTEM; REPLICATE LEAK IN THE PUMP TO ENSURE THE STATUS LIGHTS OPERATE AS REQUIRED. ANY FAILED PUMPS ARE CLEARLY LABELED AND SEGREGATED FROM THE PASSED PUMPS IN ACCORDANCE WITH OUR PROCEDURES FOR THE CONTROL OF NONCONFORMING PRODUCT. WE HAVE REVIEWED INSTRUCTIONS FOR USE (IFU) AND THIS PROVIDES GUIDANCE ON TROUBLESHOOTING ANY ISSUES ENCOUNTERED. POSSIBLE CAUSES FOR THE FAILURE OF THE PUMP ARE LISTED, ALONG WITH POTENTIAL ACTIONS TO CORRECT THE PROBLEM. WOUND HEALING WILL CONTINUE WHILE THE DRESSING REMAINS IN PLACE, UNTIL THE PUMP STATUS LIGHTS INDICATE THAT THERE IS AN ISSUE WITH THE PUMP REQUIRING TROUBLESHOOTING AS OUTLINED IN THE IFU. AN IMPROVED DESIGN OF THE PUMP WAS LAUNCHED IN (B)(4) 2012, WHICH WILL PROVIDE A NUMBER OF BENEFITS. THESE IMPROVEMENTS INVOLVE BOTH THE INTERNAL WORKINGS OF THE PUMP, AND EXTERNAL COMPONENTS. THE DESIGN OF THE BARB TO MAKE IT STRONGER AND LESS SUSCEPTIBLE TO BREAKING HAS BEEN COMPLETED. THE NEW DESIGN HAS BEEN TESTED AGAINST THE CURRENT BARB AND HAS PERFORMED FAVORABLY.

    Description of Event or Problem · 1

    FAILURE TO MAINTAIN VACUUM: THE THERAPY STOPPED WHEN A LEAK WAS DETECTED INSTEAD OF THE LEAK SYMBOL VISUAL LIGHT. THE THERAPY RESTARTED EVERY HOUR BUT AS THE LEAK HAD NOT BEEN RESOLVED, THE THERAPY STOPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237910 PICO SINGLE USE NEGATIVE PRESSURE WOUND THERAPY SYSTEM PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED) BTA SMITH & NEPHEW WOUND MANAGEMENT 66800866

    Patients

    Seq Age Sex Outcome Treatment
    1 Other