MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. PICO 7 10CM X 20CM; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Model Number	PICO 7 10CM X 20CM
Medical Device Problem Code	Pumping Stopped (1503)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/20/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that when the surgeon went to use pico7 in or all icon lights illuminated and stayed on, so the device did not work.The procedure was completed with a competitor's device and the customer would like a replacement.
Additional Manufacturer Narrative
We have now concluded our investigation for the complaint received.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.The device was intended for use in treatment.As the device was not returned, a product evaluation could not be carried out.A clinical assessment was carried out.It was concluded; ¿no patient injuries or adverse consequences were reported due to the pico device not working or the additional surgical time.The future impact to the patient beyond the procedure and the use of the replacement device cannot be determined based on the limited information provided.Should additional medical information be provided, this complaint will be re-assessed.¿ a risk management review found that the risk files for this product contains loss of negative pressure benefits as a harm resulting of device entering error state due to multiple failure modes.The ifu for this product outlines troubleshooting steps in the event that all lights are solidly illuminated.There are various reasons that the device may enter an error state (all lights illuminated), 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 10CM X 20CM
• Common Device Name: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• MDR Report Key: 10165798
• Report Number: 8043484-2020-00812
• Device Sequence Number: 16939986
• Product Code: OMP
• UDI-Device Identifier: 05000223492175
• UDI-Public: 5000223492175
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: PICO 7 10CM X 20CM
• Device Catalogue Number: 66022002
• Device Lot Number: 1949
• Initial Date Received by Manufacturer: 05/20/2020
• Supplement Date Received by Manufacturer: 07/31/2020
• Initial Report FDA Received Date: 06/17/2020
• Supplement Report FDA Received Date: 08/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention