BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENASYS GO RENTAL DEVICE

    MDR report key: 3771341 · Received April 24, 2014

    Report

    Report Number
    3006760724-2014-00319
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    August 5, 2013
    Report Date
    April 24, 2014
    Manufacturer
    SMITH & NEPHEW WOUND MANAGEMENT
    Product Code
    BTA
    PMA / PMN Number
    K083375
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS NOT CONFIRMED, UPON THE EVALUATION OF THE RETURNED DEVICE. AN EVALUATION WAS CONDUCTED TO THE PUMP AS PER "RENASYS GO PERFORMANCE AND SAFETY CHECK¿ (B)(4), MOST CURRENT REVISION). A VISUAL INSPECTION WAS CONDUCTED AND NO ANOMALIES WERE NOTED. THERE WERE NO ISSUES NOTED WITH THE VACUUM OR ALARMS ON THE PUMP. THE ROOT CAUSE FOR THE REPORTED ISSUE COULD BE ONE OF MANY RELATED TO A PUMP RESPONSE TO A CONDITION IN THE NPWT SYSTEM, NOT NECESSARILY CAUSED BY PUMP. THE PUMP WAS TESTED PER THE NORMAL TEST PROCEDURE AND IS WORKING WITHIN SPECIFICATIONS. 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 (B)(4) 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 RENASYS GO RENTAL DEVICE.

    Description of Event or Problem · 1

    FAILURE TO ALARM THIS PATIENT HAD A RENASYS GO APPLIED TO A BUTTOCK WOUND USING ONE PIECE OF BLACK FOAM. ADHESIVE GEL STRIPS WERE USED TO SECURE IT IN PLACE. REP CALLED TO CHECK ON THE PATIENT. THE PUMP WAS REGISTERING 120MMHG CONTINUOUS THERAY ¿ NO PROBLEMS IDENTIFIED. THE PATIENT SAID HE FELT ¿WET¿. WHEN I LOOKED AT HIS DRESSING, IT WAS ALMOST COMPLETELY OFF THE WOUND, YET THE PUMP DID NOT ALERT TO THIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248743 RENASYS GO RENTAL DEVICE PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED) BTA SMITH & NEPHEW WOUND MANAGEMENT 66800164R

    Patients

    Seq Age Sex Outcome Treatment
    1