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

Catalog Number UNKNOWN

Device Problem Pumping Problem (3016)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/10/2020

Event Type  malfunction  

Manufacturer Narrative

Complications during treatment have been reported for this failure mode, such as use of an alternative or competitor device to complete the procedure.As a result, this malfunction may necessitate an alternative treatment if the malfunction were to recur.This alternative treatment is considered medical or surgical intervention to preclude permanent damage to a body structure or body function.This event is considered reportable pursuant to 21 c.F.R.§803.

Event Description

It was reported that the plco 7 was placed (b)(6) 2020 over a c-section incision.Right after surgery all the lights on the device illuminated and then went back off and again sometime in the night all the lights came on again.The nurse replaced the batteries, tried to turn the power button off and on, and changed the dressing but alt lights are still solidly illuminated.She was advised per clinical guidelines that when all the lights are on together, the pump has malfunctioned for some reason and is no longer applying negative pressure to the wound and will need a new device but will not have to change the dressing again since she just changed it.She was encouraged to contact the physician for guidance on if a new device should be placed or if they would like therapy discontinued at this time.No further information available at this time.

Manufacturer Narrative

We have now completed our investigation into the reported complaint.A review of the batch manufacturing records could not be performed as no part or lot numbers were provided, however, there are no indications to suggest that the device did not meet specifications upon release into distribution.A complaint history review was carried out across all pico 7 products, there have been 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: UNKN PICO 7
• 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
• MDR Report Key: 10353724
• MDR Text Key: 201378211
• Report Number: 8043484-2020-02274
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 08/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1