BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENASYS GO RENTAL DEVICE

    MDR report key: 3860894 · Received June 10, 2014

    Report

    Report Number
    3006760724-2014-00373
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    March 12, 2014
    Report Date
    July 15, 2014
    Manufacturer
    SMITH & NEPHEW WOUND MANAGEMENT
    Product Code
    BTA
    PMA / PMN Number
    K083375
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS CONSIDERED INCONCLUSIVE. AN EVALUATION OF THE PUMP WAS CONDUCTED BY (B)(4) ON 21 MAY 2014, NO ANOMALIES OR PROBLEMS WERE FOUND, ALL ALARMS AND FUNCTIONAL TESTS PASSED SATISFACTORILY AND DEVICE CONFIRMED WORKING WITHIN SPECIFICATIONS (REFERENCE (B)(4) REVISION P). HISTORICAL REVIEW OF COMPLAINTS FOR RENASYS GO PUMP SERIAL # (B)(4) SHOWED NO PRIOR ISSUES. BASED ON EVALUATION FINDINGS DEVICE MALFUNCTION IS RULED OUT AS POSSIBLE CAUSE FOR THE ISSUE REPORTED. IN RELATION TO THE MISSING PART OF QUICK CLICK CONNECTOR, THE COMPLAINANT INDICATED THAT IT WAS CAUSED BY MISHANDLING DURING CANISTER CHANGE. DAMAGED TUBING SHOULD HAVE BEEN DISCARDED AND REPLACED TO ELIMINATE RISK OF LEAKING. ACCORDING TO THE INFORMATION PROVIDED A COMBINATION OF GAUZE AND FOAM WERE USED IN THIS WOUND WITH THE SOFT PORT DIRECTLY PLACED OVER THE FOAM. POOLING OF BLOOD WAS ONLY OBSERVED NEAR THE GAUZE SIDE OF THE DRESSING. IT IS VERY LIKELY THAT THE PUMP DID NOT ALARM WHEN A HOLE WAS CUT IN GAUZE INTERFACE BECAUSE THE SYSTEM WAS STILL REACHING AN APPROPRIATE RATE OF NEGATIVE PRESSURE THROUGH THE FOAM SIDE. THE SYSTEM IS DESIGNED TO ASSERT A LEAK ALARM WHEN FLUID HAS CLEARED THE TUBING SET AND AIR HAS BEEN FREELY FLOWING THROUGH THE TUBING IN A RATE GREATER THAN 1.0 L/MIN FOR MORE THAN ONE (1) MINUTE. IN REGARDS TO THE OBSERVED POOLING OF BLOOD IT IS DIFFICULT TO DETERMINE AND ASSIGN AN EXACT ROOT CAUSE SINCE VARIOUS ELEMENTS (I.E. SOFT PORT, WOUND FILLER) ARE INVOLVED. IT MAY BE HELPFUL TO REVIEW DRESSING APPLICATION, CHOICE OF WOUND FILLER, AND PRESSURE SETTINGS WITH CLINICIAN. PER CLINICAL GUIDELINES, AN INCREASE IN THE PRESSURE MAY BE NECESSARY ACCORDING TO SIZE OF WOUND, VISCOSITY OF EXUDATE, AMOUNT OF EXUDATE AND CLINICAL JUDGMENT OF DESIRED WOUND OUTCOMES. ADDITIONALLY, IT IS IMPORTANT THAT HOLE IN TRANSPARENT FILM IS PROPERLY CENTERED AND ALIGNED WITH OPENING IN SOFT PORT TO ENSURE A GOOD SEAL AND DECREASE RISK OF POOLING. THE COMPLAINT IS RECORDED AND ANY SIMILAR ISSUES WILL BE MONITORED THROUGH THE COMPLAINT SYSTEM.

    Description of Event or Problem · 1

    FAILURE TO ALARM. ORANGE PART OF QUICK CLICK CONNECTOR MISSING FROM THE SOFTPORT, IT MUST HAVE BEEN PULLED OFF BY NIGHT STAFF NURSE WHO CHANGED THE CANISTER THE PREVIOUS NIGHT- THE REMAINING CONNECTOR APPEARED TO FIT THE INNER TUBE OF THE SOFTPORT AND NEGATIVE PRESSURE WAS ACHIEVED AND LOOKED COMPRESSED. FLUID POOLING UNDER DRESSING AND NOT GETTING SUCTIONED AWAY BY DEVICE. NURSE CUT HOLE IN GAUZE INTERFACE AND NO ALARM SOUNDED WHEN HOLE WAS MADE IN DRESSING TO REMOVE SMALL POOL OF FLUID. NURSE INCREASED PRESSURE TO 100MMHG TO SEE IF THE EXUDATE PULLED AWAY BETTER AS IT HAD BEEN SET AT 80MMHG AS A PRECAUTION - WOUND WAS NEAR BOWEL. NURSE WAITED TO SEE IF THE PUMP WOULD ALARM (APPROX 5CM X 5CM OF RENASYS GAUZE DRESSING WAS EXPOSED TO THE AIR) THERE WAS NO ALARM AFTER 10 MINUTES.

    Description of Event or Problem · 1

    FAILURE TO ALARM. ORANGE PART OF QUICK CLICK CONNECTOR MISSING FROM THE SOFTPORT, IT MUST HAVE BEEN PULLED OFF BY NIGHT STAFF NURSE WHO CHANGED THE CANISTER THE PREVIOUS NIGHT- THE REMAINING CONNECTOR APPEARED TO FIT THE INNER TUBE OF THE SOFTPORT AND NEGATIVE PRESSURE WAS ACHIEVED AND LOOKED COMPRESSED. FLUID POOLING UNDER DRESSING AND NOT GETTING SUCTIONED AWAY BY DEVICE. NURSE CUT HOLE IN GAUZE INTERFACE AND NO ALARM SOUNDED WHEN HOLE WAS MADE IN DRESSING TO REMOVE SMALL POOL OF FLUID. NURSE INCREASED PRESSURE TO 100MMHG TO SEE IF THE EXUDATE PULLED AWAY BETTER AS IT HAD BEEN SET AT 80MMHG AS A PRECAUTION ¿ WOUND WAS NEAR BOWEL. NURSE WAITED TO SEE IF THE PUMP WOULD ALARM (APPROX 5CM X 5CM OF RENASYS GAUZE DRESSING WAS EXPOSED TO THE AIR) THERE WAS NO ALARM AFTER 10 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342488 RENASYS GO RENTAL DEVICE PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED) BTA SMITH & NEPHEW WOUND MANAGEMENT 66800164R

    Patients

    Seq Age Sex Outcome Treatment
    1