MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. PICO 7 15CM X 30CM; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Catalog Number 66802007

Device Problems Pumping Stopped (1503); Pumping Problem (3016)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/21/2021

Event Type  malfunction  

Manufacturer Narrative

Case (b)(4).

Event Description

It was reported that during set-up when the pico 7 pump was turned on, it did not suck and all the indicators lighted-up at the same time.Two pumps had the same issue.Treatment was completed with a back-up with no delay.Lot number is unknown.

Manufacturer Narrative

H3, h6: we have now completed our investigation into the reported complaint.A review of the batch manufacturing records could not be performed as no lot number was provided, however, there are no indications to suggest that the device did not meet specifications upon release into distribution.The complaint history review found further instances of the reported event.As no product could be returned, a thorough evaluation of the device could not be carried out.An image provided showed all indicator lights solidly illuminated.This confirmed a relationship between the event and the device.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 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.

Manufacturer Narrative

H10: reassessment of this incident found it not to fulfill reporting criteria.The loss of negative pressure wound therapy due to an inoperative or 'stopped' pump will not directly cause or contribute to serious injury or death as the pico dressing can revert to managing the wound as a standard multilayer dressing.No risk to patient safety is anticipated.This event is considered not reportable pursuant to 21 cfr part 803.While this event is no longer considered reportable, this report is being submitted as a courtesy to provide updated investigation results based on the return and evaluation of the complaint device subsequent to the submission of our previous supplemental report.Investigation results: we have now concluded our investigation for the complaint received.A review of the batch manufacturing records could not be performed as no lot numbers were provided, however, there are no indications to suggest that the devices did not meet specifications upon release into distribution.The complaint history file contains further instances/related events of the reported event.There is nothing to indicate that this is outside of acceptable rates of occurrence the devices were used for treatment and were returned for evaluation.An initial visual inspection did not identify any issues on the returned device - oddk460016.When fresh batteries were inserted, the device did not function.This confirmed a relationship between the event and the device.Device performance data showed that the device ran for over 7 days.As stated in the ifu, the pico 7 device is designed to provide therapy for 7 days.The device stopped providing therapy as it had reached its end-of-life time limit.The investigation has been concluded as ¿no device problem identified¿.An initial visual inspection did not identify any issues on the returned device - oddk460104.When fresh batteries were inserted, all indicator lights were solidly illuminated.This confirmed a relationship between the event and the device.Device performance data shows the device entered a non-recoverable error state due to a motor current error.The root cause was determined as a component failure.The alleged failure mode and associated potential harm(s) are mitigated in the risk files for this product.This investigation is now complete with no corrective actions required.Smith + nephew will continue to monitor for any adverse trends relating to this product range.Related case for 1st device - (b)(4)(mdr 8043484-2021-00332).

Event Description

It was reported that during set-up when the pico 7 pump was turned on, there was no suction and all the indicators illuminated at the same time.Two pumps had the same issue.Treatment was completed without delay using a back-up device.

• Brand Name: PICO 7 15CM X 30CM
• Type of Device: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2 BN; UK HU3 2BN
• Manufacturer (Section G): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2 BN; UK HU3 2BN
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 11330003
• MDR Text Key: 233274935
• Report Number: 8043484-2021-00333
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K180698
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 66802007
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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