MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. RENASYS TCH 300ML CANISTER; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Model Number	66801273
Medical Device Problem Code	False Alarm (1013)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there have been problems with the new canisters because the bag bursts when there are very few serosities in the canister.Solidifying plugs the suction port causing the pump to alarm at night.The nurses have to travel for this reason and we waste consumables so the supply is just-in-time.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, was not returned for evaluation.The supplied information was reviewed and we have not been able to establish a relationship between the reported event and the device or determine a root cause on this occasion.Probable cause includes device orientation or a failed product, the ifu offers further guidance.The manufacturing records show no evidence that the product did not meet specification at the time of manufacture.The 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 300ML CANISTER
• Common Device Name: 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: 10859746
• Report Number: 8043484-2020-03922
• Device Sequence Number: 11564163
• Product Code: OMP
• UDI-Device Identifier: 00040565126524
• UDI-Public: 00040565126524
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K153209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2021

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: 66801273
• Device Catalogue Number: 66801273
• Device Lot Number: 40714167
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/26/2020
• Supplement Date Received by Manufacturer: 04/22/2021
• Initial Report FDA Received Date: 11/18/2020
• Supplement Report FDA Received Date: 04/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1