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

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Blood Loss (2597)

Event Type  Death  

Event Description

It was reported that a patient death occurred during treatment with an unknown negative pressure wound therapy device due to bleeding.Further details on the event and the product are unknown at this time.

Manufacturer Narrative

H10: we have now concluded our investigation for the complaint received.As no product details were made available a review of batch manufacturing records could not be carried out.As no samples were returned, a product evaluation could not be carried out.A clinical assessment was carried out.The following conclusions were made; it was reported that the patient expired while a negative pressure wound therapy product was in use due to bleeding.The ifu for each smith and nephew npwt device does include warnings and precautionary statements regarding patients with a high-risk for bleeding.No product identification or clinically relevant supporting documentation was provided, therefore, a thorough medical investigation could not be performed and the root cause could not be concluded.No causal relationship between the device and the reported event could be established.Should clinical documentation become available in the future, the clinical review may be re-opened.No further medical assessment is warranted at this time.A review of the risk management files could not be carried out due to the insufficient product information provided.A complaint history review could not be carried out as the part and lot numbers are unknown.Despite several attempts to gain details regarding this event, including prosecution details, relevant details crucial to the investigation (such as product name) could not be obtained.Therefore, we have been unable to identify any cause or contribution of the smith and nephew product to the reported event and consequently, a root cause could not be determined.Should further supporting information become available, this case will be reopened.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: UNKNOWN NEGATIVE PRESSURE WOUND THERAPY SUCTION PUMP
• 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: 9269453
• MDR Text Key: 164721139
• Report Number: 8043484-2019-00768
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• 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: 01/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: UNKNOWN
• Date Manufacturer Received: 01/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death