MAUDE Adverse Event Report: SMITH AND NEPHEW RENASYS GO; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Device Problems Computer Software Problem (1112); Fluid/Blood Leak (1250); Device Displays Incorrect Message (2591); Device-Device Incompatibility (2919); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Information (3190)

Event Date 06/05/2014

Event Type  malfunction  

Event Description

The negative pressure therapy dressing and pump were applied to the surgical site of the scalp.There was a wound measuring 13.5 x 19 x 1 that was covered with a alloderm graft and a split thickness skin graft then the dressing was applied.Once applied, it was connected to the pump and therapy was initiated.Within 1-2 minutes the pump began alarming that a leak was occurring.Over the next 5 hours the dressing was replaced and repaired, the pressure settings were changed multiple times, and the pump was rebooted more than 5 times in an attempt to reset the error.At approximately the fifth hour it was noted that the pump when turned on read vo.86 on the screen.The rep for smith and nephew had informed me that if that message appeared on the screen when the machine was booting up that it meant that there was a compatibility issue.She stated that the pumps had undergone and update and the dressing kits had not.Due to this update the pumps were not reading the dressings correctly and subsequently would continue to alarm regardless of what was done to the dressing.She further stated that the only corrective measure was to change to a different pump and that the therapy should theoretically be maintained even though the alarm was continuing to go off.The surgeon and er physician were informed of the problem and that the dme company would not be able to deliver another pump until approximately 10-12am the next day.The patient was informed by me and the rep that the therapy should still be working but the pump will continue to alarm until changed to a different pump.Approximately 4 days later, the dressing was removed from the surgical site.The dressing showed areas of inconsistent suction.It was dry and stiff like cardboard.Partial areas of the split thickness skin graft were adhered to the dried out areas of the foam in the dressing that was removed.The edges of the graft were dry and black/purple.Manufacturer response for negative pressure therapy pump, renasys go (per site reporter).
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no response.

• Brand Name: RENASYS GO
• Type of Device: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
• Manufacturer (Section D): SMITH AND NEPHEW; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 3928487
• MDR Text Key: 4670189
• Report Number: 3928487
• Device Sequence Number: 1
• Product Code: OMP
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Invalid Data
• Type of Report: Initial
• Report Date: 06/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/11/2014
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 07/11/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NO OTHER THERAPIES
• Patient Age: 68 YR