MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. PICO 14 10X30CM CTN1; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Catalog Number 66802043

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/25/2020

Event Type  malfunction  

Event Description

It was reported that a pico 14 was opened and had all four lights illuminated, pump wouldn¿t vibrate or make any noise.There was no patient harm.

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 lot number was 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 using the part number provided, 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 devices could not be carried out.The devices were intended for use in treatment.It was reported that all indicator lights were solidly illuminated.This means that the devices entered a non-recoverable error state.There are various reasons that a 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 devices 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 14 10X30CM CTN1
• 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: 10557361
• MDR Text Key: 208303554
• Report Number: 8043484-2020-02908
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• PMA/PMN Number: K191760
• 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: 10/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 66802043
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1