MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. PICO 7 SINGLE DRSG 15CM X 20CM; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Catalog Number 66802016

Device Problems Pumping Stopped (1503); Noise, Audible (3273)

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

Event Date 03/11/2021

Event Type  malfunction  

Event Description

It was reported that the device was placed and 4 days later, it started to make a lot of noise and the alarm lights turned red.The professional healthcare could not reset the device and they had to change it for another device of the same reference.No patient harm reported.

Manufacturer Narrative

H3, h6: we have now concluded our investigation for the complaint received.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 found further instances of the reported event.The device, used for treatment, was returned for evaluation.An initial visual inspection did not identify any issues.When batteries were inserted the pump functioned without issue.Device performance data did not detect any system errors or faults with the pump.The pump monitors the level of air leaks into the dressing.If there is an air leak anywhere in the dressing, the pump will make several attempts to regain negative pressure (vacuum) over a period of time (this could result in a louder than normal buzzing with ok light still flashing).If it deems that the leak is too high (i.E.It will have to work too hard to maintain the vacuum), it pauses therapy and indicates the leak to the user so that it can be rectified.We have not been able to confirm a relationship between the event and the device.The investigation has been closed as ¿no device problem found¿.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.

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.The loss of negative pressure wound therapy due to an inoperative or 'stopped' pump will not directly cause or contribute to serious injury or death 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 7 SINGLE DRSG 15CM X 20CM
• 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: 11617693
• MDR Text Key: 243894124
• Report Number: 8043484-2021-00760
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• PMA/PMN Number: K112127
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 07/08/2021

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: 66802016
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2021
• Initial Date Manufacturer Received: 03/11/2021
• Initial Date FDA Received: 04/06/2021
• Supplement Dates Manufacturer Received: 06/09/2021; 07/06/2021
• Supplement Dates FDA Received: 06/29/2021; 07/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1