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

Catalog Number UNKNOWN

Device Problem Pumping Stopped (1503)

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

Event Date 12/09/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that two days after starting on pico 7 after a knee amputation, the device stopped working.The nurse tried to replace the batteries and pressing the orange button but she did not even see a light.The nurse was not sure on when the device started but surgeon instructions indicated that a dressing change need to be done on (b)(6) 2020.The nurse confirmed that the device had not gotten wet nor dropped.It is unknown how the treatment was completed, nor if there was a delay.No patient harm reported.No further information is available.

Manufacturer Narrative

We have now concluded our investigation for the complaint received.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.The complaint history file contains further instances/ related events of the reported event.The device was used for treatment.The device returned labelled (b)(4) is not thought to be associated with the event description provided.Therefore a product evaluation was not carried out.Potential causes for the issue reported are:- 1.The device detected an air leak or blockage and paused therapy so the issue could be rectified 2.The dressing was saturated and needed to be changed 3.The batteries needed to be changed 4.The device detected unsafe levels of use and so entered an error state for patient safety 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: UNKN 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: 11101414
• MDR Text Key: 224580302
• Report Number: 8043484-2020-04422
• 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,health
• Type of Report: Initial,Followup
• Report Date: 02/10/2021

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: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/10/2020
• Initial Date FDA Received: 12/31/2020
• Supplement Dates Manufacturer Received: 02/08/2021
• Supplement Dates FDA Received: 02/10/2021
• Patient Sequence Number: 1