MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. PICO 7 15CMX15CM; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Model Number	66022005
Medical Device Problem Codes	Failure to Pump (1502); Pressure Problem (3012)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the associated batch manufacturing records did not identify any issue at the point of manufacture which may have caused or contributed to the issue highlighted by the complainant.In addition it can be confirmed that all finished product specification testing was satisfied at the point of release.A complaint history review was carried out using the lot and part numbers provided, there have been no further complaints reported with this failure mode in the past three years.As no product could be returned, a thorough evaluation of the device could not be carried out.The device was intended for use in treatment.It was reported that all indicator lights were solidly illuminated.This means that the device entered a non-recoverable error state.There are various reasons that the device may enter an error state, such as out of range negative pressure, out of range power supply and an error retrieving data.If the pump does enter an error state, it must be replaced.This is a patient safety feature.We have not been able to confirm a relationship between the event and the device or identify a definitive root cause.No further actions by smith and nephew are deemed necessary at this stage.However, we will continue to monitor for any adverse trends relating to this product range.Smith and nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.
Event or Problem Description
It was reported that before treatment, when the hcp opened the kit and assembled the pump all the light indicators turned on and the pump was unable to deliver negative pressure.A backup device was available and solved the issue.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
We have now completed our investigation into the reported complaint.A review of the associated batch manufacturing records did not identify any issue at the point of manufacture which may have caused or contributed to the issue highlighted by the complainant.In addition it can be confirmed that all finished product specification testing was satisfied at the point of release.A complaint history review was carried out using the lot and part numbers provided, there have been no further complaints reported with this failure mode in the past three years.As no product could be returned, a thorough evaluation of the device could not be carried out.The device was intended for use in treatment.It was reported that all indicator lights were solidly illuminated.This means that the device entered a non-recoverable error state.There are various reasons that the device may enter an error state, such as out of range negative pressure, out of range power supply and an error retrieving data.If the pump does enter an error state, it must be replaced.This is a patient safety feature.We have not been able to confirm a relationship between the event and the device or identify a definitive root cause.No further actions by smith and nephew are deemed necessary at this stage.However, we will continue to monitor for any adverse trends relating to this product range.Smith and nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.

• Brand Name: PICO 7 15CMX15CM
• Common Device Name: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2 BN; UK HU3 2BN
• MDR Report Key: 10859617
• Report Number: 8043484-2020-03916
• Device Sequence Number: 3204097
• Product Code: OMP
• UDI-Device Identifier: 05000223492205
• UDI-Public: 05000223492205
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K180698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 66022005
• Device Catalogue Number: 66022005
• Device Lot Number: 2003
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/13/2020
• Supplement Date Received by Manufacturer: 11/13/2020
• Initial Report FDA Received Date: 11/18/2020
• Supplement Report FDA Received Date: 12/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1