MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. RENASYS TCH 800ML CANISTER W SLD; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Model Number	66801274
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that after applying and activating the renasys system, it was found that the pressure did not reach the dressing.The customer replaced the reservoir and everything was working normally.Everything indicates that the reservoir had an obstruction.No harm or injury reported.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, was not returned for evaluation.All provided information has been reviewed, we have not been able to establish a relationship between the device and the reported event or determine a root cause.Probable causes may include kinks, leaks or damaged component, ifu offers further guidance.A review of the associated batch manufacturing records confirmed that the device met manufacturing specifications at the point of release.A complaint history review found further instances of the reported event.This investigation is now complete with no further action deemed necessary.We will continue to monitor for any adverse trends relating to this product range.Smith + nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.

• Brand Name: RENASYS TCH 800ML CANISTER W SLD
• Common Device Name: 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: 11126049
• Report Number: 8043484-2021-00040
• Device Sequence Number: 11732056
• Product Code: OMP
• UDI-Device Identifier: 00040565126531
• UDI-Public: 00040565126531
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K153209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2021

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
• Operator of Device: Health Professional
• Device Model Number: 66801274
• Device Catalogue Number: 66801274
• Device Lot Number: V39579953
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/15/2020
• Supplement Date Received by Manufacturer: 06/03/2021
• Initial Report FDA Received Date: 01/06/2021
• Supplement Report FDA Received Date: 06/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1