BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENASYS GO NEGATIVE PRESSURE WOUND THERAPY

    MDR report key: 3761182 · Received April 21, 2014

    Report

    Report Number
    3006760724-2014-00196
    Event Type
    Malfunction
    Date Received
    April 21, 2014
    Date of Event
    October 18, 2013
    Report Date
    April 3, 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

    THE COMPLAINT WAS CONFIRMED, BASED ON THE EVALUATION OF THE PUMP. THE BLOCKAGE/CANISTER FULL FAILED TEST PERFORMED USING RUN WITH NO ALARM. NO LOT NUMBER INFORMATION WAS PROVIDED FOR THE SOFT PORT. THE REVIEW OF DEVICE HISTORY RECORD FOR RENASYS GO PUMP INDICATED NO DISCREPANCIES OR REWORK DURING THE MANUFACTURING OF THE DEVICE. ALL RENASYS GO PUMP GO THROUGH A SERIES OF PERFORMANCE TEST AND VISUAL CHECKS PRIOR TO RELEASE TO MARKET. THE COMPLAINT DATABASE WAS REVIEWED FOR THE SERIAL NUMBER #(B)(4); DEVICE SHOWED NO PRIOR ISSUES REPORTED. THIS EVENT AS INDICATED BY CUSTOMER COMPLAINT DID NOT RESULT IN PATIENT INJURY. AS A RESULT OF SIMILAR COMPLAINTS SMITH & NEPHEW HAS ISSUED (B)(4) TO INITIATE RENASYS PRODUCT LABELING UPDATES. THESE LABELING 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.

    Description of Event or Problem · 1

    FAILURE TO ALARM: DURING AUDITING OF RENASYS'S GO PUMP ALARM SYSTEM IT WAS NOTED THAT CANISTER WAS FULL OF EXUDATE.  THE MACHINE  WAS NOT ALARMING THAT IT WAS FULL AND NEEDED CHANGED.  WHEN TUBING WAS DISCONNECTED FROM PATIENT TO CHECK ALARM IT DID NOT SOUND AT ALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241167 RENASYS GO NEGATIVE PRESSURE WOUND THERAPY PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED) BTA SMITH & NEPHEW WOUND MANAGEMENT 66800164

    Patients

    Seq Age Sex Outcome Treatment
    1 Other