BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENASYS GO NPWT DEVICE

    MDR report key: 3813180 · Received May 15, 2014

    Report

    Report Number
    3006760724-2014-00348
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    February 27, 2014
    Report Date
    June 19, 2014
    Manufacturer
    SMITH & NEPHEW WOUND MANAGEMENT
    Product Code
    BTA
    PMA / PMN Number
    K083375
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACTIVE INVESTIGATION IN PROGRESS; RESULTS OF INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENT REPORT.

    Additional Manufacturer Narrative · 1

    THE REPORTED COMPLAINT IS DEEMED INCONCLUSIVE. AN EVALUATION WAS NOT POSSIBLE, UNIT WAS NOT RETURNED AND NO LOT NUMBER INFORMATION WAS PROVIDED, THEREFORE, A ROOT CAUSE FOR THE REPORTED ISSUE CANNOT FIRMLY DETERMINED. IN REGARDS TO A PUMP NOT TRIGGERING AN ALARM IN PRESENCE OF POOLING OR LEAKING, A PARTIAL BLOCKAGE MAY HAVE LED TO THE OBSERVED ISSUE. IT IS VERY LIKELY THE PUMP DID NOT ALARM BECAUSE THE SYSTEM WAS STILL REACHING VACUUM IN PRESENCE OF PARTIAL BLOCKAGE (POTENTIALLY CAUSED BY CLOTTING AT THE HEAD OF THE SOFT PORT). 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 FOR MORE THAN 1 (ONE) MINUTE. THIS IS SUPPORTED BY THE COMPLAINT DESCRIPTION STATING THAT A TECHNICAL EVALUATION CONCLUDED THAT THE HOLE IN THE SOFT-PORT WAS TOO BIG, ALLOWING GAUZE TO BE SUCKED INTO THE HOLE. IN ACCORDANCE WITH CLINICAL GUIDELINES, IT IS IMPORTANT THAT HOLE IN TRANSPARENT FILM BE CUT TO 0.6CM AND OPENING IN SOFT PORT IS PROPERLY ALIGNED WITH OPENING IN TRANSPARENT FILM TO ENSURE A GOOD SEAL AND DECREASE RISK OF INCONSISTENT ALARMS.

    Description of Event or Problem · 1

    THERE IS WOUND EXUDATE UNDER THE FOIL AND THE PUMP IS NOT GIVING ANY ALARM. THE TECHNICIAN FROM THE (B)(4) WAS ALSO INFORMED ABOUT THIS PROBLEM AND HE TESTED THE GO. HIS CONCLUSION WAS THAT THERE IS NOTHING WRONG WITH THE PUMP, BUT THE HOLE IN THE SOFT-PORT IS TOO BIG. THE PUMP SUCKS THE GAUZE INTO THE HOLE AND ONLY THE SOFT-PORT IS GETTING A VACUUM.

    Description of Event or Problem · 1

    THERE IS WOUND EXUDATE UNDER THE FOIL AND THE PUMP IS NOT GIVING ANY ALARM. THE TECHNICIAN WAS ALSO INFORMED ABOUT THIS PROBLEM AND HE TESTED THE GO. HIS CONCLUSION WAS THAT THERE IS NOTHING WRONG WITH THE PUMP, BUT THE HOLE IN THE SOFT-PORT IS TOO BIG. THE PUMP SUCKS THE GAUZE INTO THE HOLE AND ONLY THE SOFT-PORT IS GETTING A VACUUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291328 RENASYS GO NPWT DEVICE RENASYS GO NPWT DEVICE BTA SMITH & NEPHEW WOUND MANAGEMENT 66800164

    Patients

    Seq Age Sex Outcome Treatment
    1