BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENASYS GO RENTAL DEVICE

    MDR report key: 3651111 · Received February 27, 2014

    Report

    Report Number
    3006760724-2014-00023
    Event Type
    Malfunction
    Date Received
    February 27, 2014
    Date of Event
    January 31, 2014
    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 Location
    EI
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE REPORTED COMPLAINT WAS NOT CONFIRMED. AN EVALUATION OF THE PUMP WAS CONDUCTED AT THE (B)(4) SERVICE CENTER ON 04 MARCH 2014 NO ANOMALIES OR PROBLEMS WERE FOUND, THE PUMP PASSED ALL FUNCTIONAL TESTS AND CONFIRMED WORKING WITHIN SPECIFICATIONS (REFER TO RA#203119-001). BASED ON EVALUATION FINDINGS, IT WAS CONFIRMED THAT ALL ALARMS WERE OPERATING CORRECTLY; THEREFORE DEVICE MALFUNCTION IS RULED OUT AS POSSIBLE CAUSE. SINCE THE NEGATIVE PRESSURE WOUND THERAPY INVOLVES VARIOUS ELEMENTS, IT IS DIFFICULT TO DETERMINE WHAT COULD HAVE CAUSED THE USER TO EXPERIENCE THE REPORTED ISSUE. POSSIBLE CAUSES COULD BE ATTRIBUTED TO THE FOLLOWING FACTORS: 1) WOUND BED PREPARATION, 2) DRESSING APPLICATION TECHNIQUE, 3) DEVICE PLACEMENT, AND 5) DEVICE SETTINGS. NO INFORMATION WAS GIVEN ON WOUND LOCATION, DRESSING APPLICATION, PUMP PLACEMENT, CHOICE OF WOUND FILLER, AND PRESSURE SETTINGS. BASED ON THE LIMITED INFORMATION PROVIDED, IT MAY BE HELPFUL TO REVIEW DRESSING APPLICATION. IN ACCORDANCE WITH CLINICAL GUIDELINES, IT IS IMPORTANT THAT HOLE IN TRANSPARENT FILM BE CUT TO 0.6CM AND OPENING IN SOFT PORT IS PROPERLY ALIGNED WITH OPENING IN TRANSPARENT FILM TO ENSURE A GOOD SEAL. NO FURTHER ACTIONS ARE NECESSARY. THERE ARE NO INDICATIONS OF 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

    FAILURE TO ALARM NO PUMP ALARM SOUNDING DESPITE THE FACT THAT NEGATIVE THERAPY WAS NOT BEING DELIVERED TO THE WOUND BED. EVIDENCED BY THE FACT THERE WAS NO DEPRESSION OF BLACK FOAM. THERE WAS NO POOLING OF FLUID - PATIENT STATED THAT THE PUMP HAD ALARMED AT 7AM BUT FOR A SHORT TIME ONLY. RENASYS LIGHT WAS GREEN. DISTAL END OF SOFT PORT DRESSING HAD NO FIRM SUBSTANCE IN IT.

    Description of Event or Problem · 1

    FAILURE TO ALARM. NO PUMP ALARM SOUNDING DESPITE THE FACT THAT NEGATIVE THERAPY WAS NOT BEING DELIVERED TO THE WOUND BED. EVIDENCED BY THE FACT THERE WAS NO DEPRESSION OF BLACK FOAM. THERE WAS NO POOLING OF FLUID - PATIENT STATED THAT THE PUMP HAD ALARMED AT 7AM BUT FOR A SHORT TIME ONLY. RENASYS LIGHT WAS GREEN. DISTAL END OF SOFT PORT DRESSING HAD NO FIRM SUBSTANCE IN IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121618 RENASYS GO RENTAL DEVICE PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED) BTA SMITH & NEPHEW WOUND MANAGEMENT 66800164R

    Patients

    Seq Age Sex Outcome Treatment
    1 Other