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

Catalog Number UNKNOWN

Device Problem Power Problem (3010)

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

Event Date 09/28/2020

Event Type  malfunction  

Event Description

It was reported that therapy was started on (b)(6) 2020 to treat a cesarean section incision, on (b)(6) 2020 the patient took a shower, disconnected the battery pack and reconnected it 1-2 hours later.On (b)(6) 2020 the patient noticed that all lights were solidly illuminated.Batteries were changed but the issue continued.No further information is available.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

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.The device was used for treatment.As no product could be returned, a thorough evaluation of the device could not be carried out.It was reported that all indicator lights were solidly illuminated after the patient took a shower.When all lights are illuminated, this means that the device entered a non-recoverable error state.This is a patient safety feature.As stated in the ifu for this product, prior to showering the pump must be stopped, disconnected from the tubing and placed in a safe location where it will not get wet.If these steps are not directly followed, moisture may damage the internal components of the device.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
• 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
• MDR Report Key: 10727166
• MDR Text Key: 212751750
• Report Number: 8043484-2020-03275
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• PMA/PMN Number: K180698
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 11/16/2020

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
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/28/2020
• Initial Date FDA Received: 10/23/2020
• Supplement Dates Manufacturer Received: 11/13/2020
• Supplement Dates FDA Received: 11/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1