MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. PICO WITH SOFT PORT 15X20CM; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Catalog Number 66801362

Device Problem Pumping Problem (3016)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/25/2020

Event Type  malfunction  

Event Description

It was reported that the pico soft port 15 x 20cm stop working.The device stopped working during the wound treatment.This is her 3rd pico soft port 15 x 20cm used on her wound treatment.First time patient encounter this situation where the ok, leakage & low batt signal light are on at one go.Pico pump didn¿t perform suction as usual, stop its function.

Manufacturer Narrative

H10: the information received by the manufacturer has been re-evaluated for mdr reporting and it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.Suction failure resulting in the loss of negative pressure wound therapy will not directly cause or contribute to serious injury or death, even in a clinical setting 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.

• Brand Name: PICO WITH SOFT PORT 15X20CM
• 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: 10439366
• MDR Text Key: 203972211
• Report Number: 8043484-2020-02565
• Device Sequence Number: 1
• Product Code: OMP
• UDI-Device Identifier: 04582111154835
• UDI-Public: 4582111154835
• Combination Product (y/n): N
• PMA/PMN Number: K112127
• 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: 07/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 66801362
• Device Lot Number: 020618
• Date Manufacturer Received: 07/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1