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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 RENTAL DEVICE
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SMITH & NEPHEW WOUND MANAGEMENT RENASYS GO NPWT DEVICE; RENASYS GO RENTAL DEVICE Back to Search Results
Model Number 66800164R
Device Problems Device Alarm System (1012); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/04/2013
Event Type  malfunction  
Event Description
Failure to alarm: couldn¿t get the machine to keep working for more than 1 or 2 days, although we were getting a good seal on the dressing.Patient would say the dressing had ¿gone soft¿ although the pump had not alarmed to tell him of the malfunction.
 
Manufacturer Narrative
Additional investigation in-progress, results of the investigation will be provided in a supplement report.This medical device report (mdr) is being submitted by smith & nephew as a result of a retrospective review of complaints, including adverse events, as part of corrective and remediation actions following the issuance of the 483 issued november 26, 2013 to smith & nephew, inc.Fei no: (b)(4).Smith & nephew is performing a two-year retrospective review of complaint files to re-assess reportability criteria and reporting decisions made for complaint recorded during the time period under review.This complaint has been re-assessed in accordance under the provisions of 21cfr 803.50 and deemed reportable as an mdr.We are submitting one (1) initial, 30 day report, medwatch fda form 3500a, for a purported device malfunction which occurred while using the renasys go negative pressure wound therapy device.
 
Manufacturer Narrative
On (b)(4) 2013, smith & nephew received the above reported complaint for an adverse incident.No pictures, no samples and no soft port lot number information were provided for evaluation.A device history record (dhr) review for serial #(b)(4) could only be reviewed.The dhr review noted no discrepancy during manufacturing of the device.A visual/performance inspection conducted by hugo technology (service provider), confirmed a cracked back case.The pump met the preliminary criteria set forth per the performance & safety check record sheet.Since, the negative pressure therapy involves various elements within a system (i.E.Pump, canister, soft port etc.), it is difficult to determine and assign a definitive root cause of the complaint described.Most probable causes based on the description of event for the soft port gone soft, saturated, and leaking under the drape are: blockage caused by clotting at the head of the soft port with blood clots/exudate.Gradual blockage/buildup of blood clots/exudate inside the soft port fluid handling pathway.As a result of similar 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.(b)(4).
 
Event Description
Failure to alarm: couldn¿t get the machine to keep working for more than 1 or 2 days, although we were getting a good seal on the dressing.Patient would say the dressing had ¿gone soft¿ although the pump had not alarmed to tell him of the malfunction.
 
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Brand Name
RENASYS GO NPWT DEVICE
Type of Device
RENASYS GO RENTAL DEVICE
Manufacturer (Section D)
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, MD 33716
7273993785
MDR Report Key3652601
MDR Text Key4281144
Report Number3006760724-2014-00034
Device Sequence Number1
Product Code BTA
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K083375
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 04/17/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Nurse
Device Model Number66800164R
Device Lot NumberKGUL121255
Is the Reporter a Health Professional? No
Distributor Facility Aware Date11/04/2013
Event Location Hospital
Initial Date Manufacturer Received 11/04/2013
Initial Date FDA Received02/28/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received04/18/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? Yes
Patient Sequence Number1
Patient Outcome(s) Other;
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