MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. PICO 7 10CM X 40CM; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Catalog Number 66802004

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Chest Pain (1776); Hematoma (1884); Hernia (2240); Impaired Healing (2378); Decreased Respiratory Rate (2485)

Event Date 03/02/2023

Event Type  Injury  

Event Description

It was reported that, during the fifth day of negative pressure would treatment with pico 7 10cm x 40cm on a thoracotomy scar, which had been placed immediately postoperatively, the patient experienced exacerbation of pain and respiratory status.A computed tomography (ct) scan was performed, revealing a pulmonary hernia with an hematoma.The consequences were marked by worsening hypoxemia and the need for surgical management.Surgical reanimation was performed.The patient was in intensive care at day 1 post operatory.The medical teams stopped using the pico as there was a doubt about a contraindication to its use following a thoracotomy.Patient's outcome is favorable after additional surgery.

Manufacturer Narrative

Internal complaint reference: (b)(4).

Manufacturer Narrative

Additional information: h6 (component code, type of investigation, investigation findings, investigation conclusions).Results of investigation: it was reported that, during the fifth day of negative pressure would treatment with pico 7 10cm x 40cm, which had been placed on a thoracotomy scar immediately postoperatively, the patient experienced exacerbation of pain and respiratory status.A computed tomography (ct) scan was performed, revealing a pulmonary hernia with an hematoma.The consequences were marked by worsening hypoxemia and the need for surgical management.Surgical reanimation was performed.The patient was in intensive care at day 1 post operatory.Patient's outcome is favorable after additional surgery, he is now out of the woods and doing better.The device (the pico 7 pump unit) was returned for analysis.When the supplied batteries were inserted, the device powered up but did not activate with a button press.Fresh batteries were inserted and yielded the same result - the device powered up but did not then activate.Device performance data found the device ran for a total of 7 days 6 hours 38 minutes and 52 seconds - this device had reached it's end of life.A leak reading was recorded for a period of 3 days 5 hours 24 minutes and 35 seconds.A filter blocked reading was recorded for a period of 3 days 13 hours 10 minutes and 18 seconds.An enhanced analysis was then carried out, and which provided the device state during it's life of approximately 174 hours.Notably, the device recorded a filter blocked state (state 6 - device is in filter block state, the device has recognised that the filter located in the soft-port component has become occluded) from approximately hour 2 to approximately hour 90 of it's life, and detected a leak (state 2 - device is in leak state, the device has detected a leak in the system) from approximately hour 90 to approximately hour 174.A lot number was provided and the batch records were reviewed.The record(s) confirmed that the batch as a whole had progressed through a satisfactory release process, which involved testing selected samples of the product against the requirements of the finished product specification.Furthermore, the record(s) did not indicate any technical or other issue identified during the manufacturing process for this particular batch, that could have caused or contributed to the complaint problem.A complaint history review revealed one complaint of a similar nature, reported by the same health care professional/facility and within the same user report to smith & nephew (internal reference number: (b)(4), mdr reference number: 8043484-2023-00021) the ifu has been reviewed and contains comprehensive instructions on the safe operation and use of the device, including guidance on the suitability of the device for different wound types and correct application of the dressing.Specifically, section 2 of the ifu details the indications for use and section 3 outlines the contraindications for use of the device.A clinical evaluation was conducted, during which the following observations and conclusions were made: the pico 7 was in use for 5 days prior to the pain and worsening respiratory status was reported.The provided analysis of a requested ct scan revealed a pulmonary hernia with a hematoma.The reported assessment of worsening hypoxemia indicated a need for surgical intervention.Per report, the surgeon performed a surgical re-animation procedure, and the patient was transferred by the surgeon to the intensive care unit for the first post-operative day.The surgeon reported the patient¿s condition as favorable.All documents provided as of this date have been reviewed and considered and unless noted do not contribute to the clinical/medical investigation.Based on the limited information provided the definitive clinical root cause of the reported adverse events could not be confirmed.The reported pain and worsening respiratory status does correlate with the ct scan findings of pulmonary hernia with a hematoma and the reported worsening hypoxemia.There is no evidence to support the pico device contributed to the event as it was reported used per indications which would be on a closed surgical incision only.The pico device would act as a dressing only with the pump on or off, and if on and functioning would not provide negative pressure on a closed thoracotomy incision if the incision is intact and therefore would not precipitate a pulmonary hernia.A pulmonary hernia is a known complication of a thoracotomy procedure independent of the pico npwt dressing.The pulmonary hernia is likely complication of incomplete incision closure or reopening of the incision or impaired healing of the surgical incision that could have led to the herniation of the lung.The patient¿s complex procedure (esophagus removal with unreported etiology) could also play a role.Based on the complaint, the pico 7 was placed on the thoracotomy scar immediately post procedure.An unintentional user error cannot be ruled out as a potential contributing factor.The ifu, which was reported as followed by the reporter, for the pico 7 single use negative pressure wound therapy system user manual, the pico 7 should not be used for the purpose of pleural, mediastinal or chest tube drainage or surgical suction.We also cannot rule out the patient¿s age coupled with a history of 40 pack-years of smoking as a likely contributory factor to the worsening respiratory status.It was reported, the patient is 'out of the woods' and doing better.Therefore, the impact to the patient beyond that which has already been reported cannot be confirmed nor concluded.The risk management documentation for pico has been reviewed to assess whether the alleged failure and associated harms have been anticipated.With no clear failure of the device outlined within the complaint description to determine the associated hazard within the risk file, a review of (b)(4) confirmed ¿delayed wound healing¿, ¿wound deterioration¿ and ¿bleeding¿ are captured as foreseeable harms against numerous potential failures, with a residual risk rating of ¿med¿.The complaint description confirms that the device was not being used in a way that was contraindicated and the clinical review states 'there is no evidence to support the pico device contributed to the event as it was reportedly used per indications which would be on a closed surgical incision only.The pico device would act as a dressing only with the pump on or off and if on and functioning would not provide negative pressure on a closed thoracotomy incision if the incision is intact and therefore would not precipitate a pulmonary hernia.A pulmonary hernia is a known complication of a thoracotomy procedure independent of the pico npwt dressing', therefore no further action is required at this time.A risk management review was conducted and which mitigated the reported issue with no further action or updates required.A review of historical records concluded that there are no prior escalated actions related to this product and the reported event.The probable root cause for this complaint cannot be determined.There is no evidence to suggest that the smith and nephew device in any way contributed to the patient's decline in health.The device data suggests that a filter block and then a leak were detected by the pump ¿ this does not indicate that the pump was malfunctioning, it would however suggest that user error might be a contributory factor if the pump¿s visual indicators were illuminated, but were either not seen by attending medical staff or were seen but no action was taken to resolve the issue(s).As outlined within the clinical review, other likely contributory factors are the patient's age and lifestyle, and medical conditions that cannot be attributed to the use of the pico system, or any failure by this system to perform as intended.It is of note that it was initially reported by the surgeon that the pico 7 was applied in a contraindicated manner, in conjunction with chest tube drainage, however this was later retracted.No further actions by smith & nephew are deemed necessary at this stage.However, we will continue to monitor for any adverse trends relating to this product range.Corrected data: b5 (narrative), d9,h3 (device returned to manufacturer for analysis), e2 (initial reporter did not send a report to fda), h6 (health effect - clinical code, health effect - impact code).

Event Description

It was reported that, during the fifth day of negative pressure would treatment with pico 7 10cm x 40cm, which had been placed on a thoracotomy scar immediately postoperatively, the patient experienced exacerbation of pain and respiratory status.A computed tomography (ct) scan was performed, revealing a pulmonary hernia with an hematoma.The consequences were marked by worsening hypoxemia and the need for surgical management.Surgical reanimation was performed.The patient was in intensive care at day 1 post operatory.Patient's outcome is favorable after additional surgery, he is now out of the woods and doing better.

• Brand Name: PICO 7 10CM X 40CM
• Type of Device: 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
• Manufacturer (Section G): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 16632315
• MDR Text Key: 312190243
• Report Number: 8043484-2023-00020
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 08/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 66802004
• Device Lot Number: 2247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 80 KG