BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENASYS GO RENTAL DEVICE

    MDR report key: 3813191 · Received May 15, 2014

    Report

    Report Number
    3006760724-2014-00347
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    January 3, 2014
    Report Date
    May 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

    AFTER AN EVALUATION OF THE RETURNED DEVICE THIS COMPLAINT WAS NOT CONFIRMED. AN EVALUATION OF THE PUMP WAS CONDUCTED BY HUGO TECHNOLOGIES ON (B)(4) 2014, NO ANOMALIES OR PROBLEMS WERE FOUND, THE PUMP PASSED ALL FUNCTIONAL TESTS AND DEEMED WORKING WITHIN SPECIFICATIONS. PARTICULARLY, STEP 33 TO 41 OF THE PERFORMANCE AND SAFETY CHECK CONFIRMED LEAK ALARMS WORKED AS EXPECTED ((B)(4). THE ROOT CAUSE FOR THE REPORTED ISSUE IS DEEMED UNDETERMINED. THE COMPLAINT DATABASE WAS REVIEWED FOR RENASYS GO PUMP SERIAL # (B)(4) AND NO OTHER ISSUES HAVE BEEN REPORTED FOR THIS UNIT. LOSS OF DRESSING ADHESION COULD BE ATTRIBUTED TO A COMBINATION OF FACTORS SUCH AS WOUND LOCATION, PATIENT MOBILITY, CONSTANT FRICTION, PRESSURE DIRECTLY APPLIED TO WOUND SITE, ACCUMULATION OF MOISTURE UNDERNEATH THE DRESSING, AND PROPER PREPARATION OF THE PERIWOUND SKIN AS PER CLINICAL GUIDELINES. IN REGARDS TO A PUMP NOT TRIGGERING A LEAK ALARM, THE MOST PROBABLE CAUSE WAS THAT THE SYSTEM WAS MAINTAINING NEGATIVE PRESSURE AS A RESULT OF A PARTIAL BLOCKAGE AND A LEAK NOT SIGNIFICANT ENOUGH IN ORDER TO TRIGGER AN ALARM. TYPICALLY, PARTIAL BLOCKAGES ARE CAUSED BY CLOTTING AT THE HEAD OF THE SOFT PORT OR BUILDUP OF BLOOD CLOTS/EXUDATE INSIDE THE WOUND FILLER (FOAM) AND/OR THE SOFT PORT FLUID HANDLING PATHWAY. IN RESPONSE TO FAILURE TO ALARM 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. PER THE INFORMATION PROVIDE THERE WERE NO PATIENT INJURIES OR HARM ASSOCIATED WITH THIS ISSUE. THE COMPLAINT IS RECORDED AND ANY SIMILAR ISSUES WILL BE MONITORED THROUGH THE COMPLAINT SYSTEM.

    Description of Event or Problem · 1

    THE PATIENT BELIEVES THERE IS A FAULT WITH THE PUMP AS ON TWO OCCASIONS THERE HAS BEEN SEROUS FLUID OOZING FROM THE WOUND, INDICATING A LEAK, WITH NO PUMP ALARM. ON ONE OCCASION THE STICKY DRESSING WAS PRACTICALLY HANGING OFF AND THERE WAS NO ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290930 RENASYS GO RENTAL DEVICE PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED) BTA SMITH & NEPHEW WOUND MANAGEMENT 66800164R

    Patients

    Seq Age Sex Outcome Treatment
    1