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

Catalog Number	66022002
Medical Device Problem Code	Suction Failure (4039)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/21/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that 3 pico kits out of the same pack with the same lot number failed.Right out of the box all lights lighted up and it was not possible to get a seal with the green ok light.A backup was available.
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 devices were intended for use in treatment.As the devices were not returned, a product evaluation could not be carried out.It is likely that the devices 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.
Additional Manufacturer Narrative
H10.H3,h6: 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 used for treatment.The returned device underwent a product evaluation.An initial visual inspection did not identify any issues.When fresh batteries were inserted the device functioned without issue.The device was powered up for a total of 4.83 days.The device spent 96.13% of its total on time in a leak state.During a functional test the device reached negative pressure wound therapy without issue.A leak can be caused for numerous reasons including; dressing not applied properly, without creases and fixation strips.Filter/port not adhered to dressing correctly.Connector not correctly fastened and secured to the pump.Tubing trapped, folded over/kinked causing a blockage.Dressing integrity has been compromised.Skin has not been thoroughly dried before application of the dressing causing the dressing to not sufficiently adhere to the skin.We have not been able to confirm a relationship between the event and the device.The investigation has been concluded as 'no problem found'.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 ; UK
• MDR Report Key: 10213785
• Report Number: 8043484-2020-01230
• Device Sequence Number: 16797742
• Product Code: OMP
• UDI-Device Identifier: 05000223492175
• UDI-Public: 5000223492175
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K112127
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/18/2020

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 Catalogue Number: 66022002
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/12/2020
• Supplement Date Received by Manufacturer: 08/14/2020; 09/16/2020
• Initial Report FDA Received Date: 06/30/2020
• Supplement Report FDA Received Date: 08/19/2020; 09/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1