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

Catalog Number 66802005

Device Problem Pumping Problem (3016)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/27/2020

Event Type  malfunction  

Event Description

It was reported that the pico 7 15cm x 15cm had all lights on as if the treatment cycle was completed, batteries were removed and paced back in, however the lights remained on.The procedure was successfully completed without delay using a back-up device.No patient injury or other complications were reported.

Manufacturer Narrative

H3, h6: the device, used in treatment, has not been returned for evaluation.However, photographic evidence has been provided.A visual inspection of the photograph reported that all indicator lights were solidly illuminated, establishing a relationship between the device and the reported event.Root cause identified as a non recoverable error due to a defective pump.A review of the manufacturing records found that there was no evidence that the product didn¿t meet specifications at the time of manufacture.A complaint history review found further instances of the reported event.This investigation is now complete with no further action deemed necessary, smith + nephew will continue to monitor for any adverse trends relating to this product range.

• Brand Name: PICO 7 15CM X 15CM
• 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: 10411864
• MDR Text Key: 203082429
• Report Number: 8043484-2020-02519
• Device Sequence Number: 1
• Product Code: OMP
• UDI-Device Identifier: 04582111156402
• UDI-Public: 4582111156402
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 07/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 66802005
• Device Lot Number: 201936
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 30 YR