BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENASYS GO NPWT DEVICE

    MDR report key: 3833569 · Received May 27, 2014

    Report

    Report Number
    3006760724-2014-00369
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    October 31, 2013
    Report Date
    July 14, 2014
    Manufacturer
    SMITH & NEPHEW WOUND MANAGEMENT
    Product Code
    BTA
    PMA / PMN Number
    K083375
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 WAS NOT CONFIRMED. COMPLIANT DESCRIPTION CITES TWO PUMPS WITH MULTIPLE CRACKS, HOWEVER, ONLY ONE PUMP WAS RETURNED FOR EVALUATION. AN EVALUATION OF THE PUMP WAS CONDUCTED AT THE (B)(4) FACILITY ON 08 JANUARY 2014, NO ANOMALIES OR PROBLEMS WERE FOUND, THE PUMP WAS FOUND FREE OF EXTERNAL DAMAGES, PASSED ALL FUNCTIONAL TESTS AND CONFIRMED WORKING WITHIN SPECIFICATIONS AS PER PROCESS SUMMARY 12000412 REV. K STEPS 9.3.3 THRU 9.3.12 (REFER TO SN #(B)(4)) REVIEW OF COMPLAINTS HISTORY FOR RENASYS GO PUMP SERIAL # (B)(4) INDICATES NO OTHER ISSUES HAVE BEEN REPORTED AGAINST THIS DEVICE. BASED ON EVALUATION FINDINGS, A DEVICE MALFUNCTION IS RULED OUT AS POSSIBLE CAUSE FOR THE ISSUE REPORTED. SINCE THE NEGATIVE PRESSURE WOUND THERAPY INVOLVES VARIOUS ELEMENTS, IT IS DIFFICULT TO DETERMINE AND ASSIGN AN EXACT ROOT CAUSE FOR THE DRAINAGE POOLING AND WOUND INFECTION ISSUE REPORTED. POOLING OF EXUDATE ON WOUND BED COULD BE ATTRIBUTED TO ONE OR A COMBINATION OF THE FOLLOWING FACTORS: INSUFFICIENT VACUUM APPLIED, PUMP POSITIONED ABOVE THE WOUND SITE, PARTIAL BLOCKAGE CAUSED BY CLOTTING AT THE HEAD OF THE SOFT PORT OR BUILDUP OF BLOOD CLOTS/EXUDATE INSIDE THE WOUND FILLER (FOAM/GAUZE), SOFT PORT NOT CORRECTLY ALIGNED WITH HOLE IN TRANSPARENT FILM, AND INADEQUATE HOLE SIZE IN TRANSPARENT FILM. NO INFORMATION WAS GIVEN ON EXACT WOUND LOCATION, SIZE, AND TYPE OF DRESSING APPLICATION, PUMP PLACEMENT, AND PRESSURE SETTINGS. ADDITIONALLY, THERE IS NO MENTION OF INITIAL WOUND CONDITION, WOUND BED APPEARANCE, AMOUNT AND APPEARANCE OF WOUND EXUDATE OR PRESENCE OF UNTREATED INFECTION. THE COMPLAINT IS RECORDED AND ANY SIMILAR ISSUES WILL BE MONITORED THROUGH THE COMPLAINT SYSTEM.

    Description of Event or Problem · 1

    FAILURE TO ALARM. WHEN THE PUMP IS RUNNING, ALARMS DID NOT INDICATE, BUT DRAINAGE WOULD START TO POOL AT THE WOUND BED. DUE TO CONSTANT POOLING OF DRAINAGE AT THE WOUND BED, PATIENT GOT A WOUND INFECTION.

    Description of Event or Problem · 1

    FAILURE TO ALARM. WHEN THE PUMP IS RUNNING, ALARMS DID NOT INDICATE, BUT DRAINAGE WOULD START TO POOL AT THE WOUND BED. DUE TO CONSTANT POOLING OF DRAINAGE AT THE WOUND BED, PATIENT GOT A WOUND INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310428 RENASYS GO NPWT DEVICE PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED) BTA SMITH & NEPHEW WOUND MANAGEMENT 66800164

    Patients

    Seq Age Sex Outcome Treatment
    1 Other