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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW WOUND MANAGEMENT RENASYS GO NPWT DEVICE; RENASYS GO NEGATIVE PRESSURE WOUND THERAPY DEVICE
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SMITH & NEPHEW WOUND MANAGEMENT RENASYS GO NPWT DEVICE; RENASYS GO NEGATIVE PRESSURE WOUND THERAPY DEVICE Back to Search Results
Model Number 66800164
Device Problems Device Alarm System (1012); Partial Blockage (1065); Detachment Of Device Component (1104); Leak/Splash (1354); Suction Problem (2170); Device Displays Incorrect Message (2591)
Patient Problems Tissue Breakdown (2681); Fluid Discharge (2686)
Event Date 03/21/2014
Event Type  malfunction  
Event Description
Maceration from loaner unit for apria.Nurse called c/o maceration r/t the dressing being wet.She also c/o leak alarm not sounding when there was a visible leak.Foam dressing with soft port, continuous 90mmhg display message at the time of leak, dressing changed every mwf, and the pt is keeping the device above the wound.Minimal amount of drainage and 30ml remains in the wound.The dressing was detached and the device did not alarm detecting a leak even after she removed the dressing completely.The device did not alarm within 3 minutes of removing the dressing.This is how she described the dressing application: skin prep to peri wound, window framed the wound, and applied strips of gel patch to the peri wound and then attached the soft port.Tested the blockage alarm and the device did not detect a blockage within 4 minutes.Tested the low vacuum alarm and the device did detect a low vacuum.
 
Manufacturer Narrative
Active investigation in process; results of the investigation will be submitted in a supplement report.
 
Manufacturer Narrative
After investigation the reported complaint was determined inconclusive.A technical evaluation was conducted at (b)(6) facility on 27 june 2014, no anomalies or damages were found, device passed all functional testing and confirmed working within specification per process summary 12000412 rev.K steps 9.3.3 thru 9.3.12( (b)(4)) 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.Since the negative pressure wound therapy involves various elements (i.E.Soft port, wound filler, pump), it is difficult to determine and assign an exact root cause.It is very likely the pump did not alarm in presence of a visible leak because the system was still reaching vacuum in presence of partial blockage 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.The system is designed to assert a leak alarm when the fluid has cleared the tubing set and air has been freely flowing through the tubing for more than 1(one) minute.The complaint is recorded and any similar issues will be monitored through the complaint system.
 
Event Description
Maceration from loaner unit for apria.Nurse called c/o maceration r/t the dressing being wet.She also c/o leak alarm not sounding when there was a visible leak.Foam dressing with soft port, continuous 90mmhg display message at the time of leak, dressing changed every mwf, and the pt is keeping the device above the wound.Minimal amount of drainage and 30ml remains in the wound.The dressing was detached and the device did not alarm detecting a leak even after she removed the dressing completely.The device did not alarm within 3 minutes of removing the dressing.This is how she described the dressing application: skin prep to peri wound, window framed the wound, and applied strips of gel patch to the peri wound and then attached the soft port.Tested the blockage alarm and the device did not detect a blockage within 4 minutes.Tested the low vacuum alarm and the device did detect a low vacuum.
 
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Brand Name
RENASYS GO NPWT DEVICE
Type of Device
RENASYS GO NEGATIVE PRESSURE WOUND THERAPY DEVICE
Manufacturer (Section D)
SMITH & NEPHEW WOUND MANAGEMENT
970 lake carillon drive
suite 110
st. petersburg FL 33716
Manufacturer (Section G)
SMITH & NEPHEW WOUND MANAGEMENT
970 lake carillon drive
suite 110
st. petersburg FL 33716
Manufacturer Contact
terry mcmahon
970 lake carillon drive
suite 110
st. petersburg, FL 33716
7273993785
MDR Report Key3829573
MDR Text Key4448196
Report Number3006760724-2014-00361
Device Sequence Number1
Product Code BTA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K083375
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 07/15/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/23/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number66800164
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/27/2014
Is the Reporter a Health Professional? No
Distributor Facility Aware Date03/28/2014
Date Manufacturer Received03/28/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Patient Sequence Number1
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