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 Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/16/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the renasys touch device gives a "container full" alarm without being so.They put in a new 300 ml container and the device keeps giving the same alarm, they modify the cure, the sealing system and it keeps failing.This happens twice, on friday the 16th and again on monday the 19th.It must be because both the 300ml containers and the renasys sealing kits are not from optimized batches.We place new optimized batches and there are no alarms.The procedure finished with a smith and nephew backup device.Surgical delay greater than 30 minutes.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, has been received and evaluated.Visual inspection found no defects.The evaluation confirmed the reported event, establishing a relationship between the device and the reported event.The root cause was determined as a failed component.A review of the associated batch manufacturing records confirmed that the device met manufacturing specifications at the point of release.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: 10821125
• Report Number: 8043484-2020-03838
• Device Sequence Number: 19580332
• Product Code: OMP
• UDI-Device Identifier: 00040565126524
• UDI-Public: 00040565126524
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 05/26/2021

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: 33014768
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2021
• Initial Date Received by Manufacturer: 10/19/2020
• Supplement Date Received by Manufacturer: 05/13/2021
• Initial Report FDA Received Date: 11/11/2020
• Supplement Report FDA Received Date: 05/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: RENASYS TCH 300ML CANISTER / 66801273; RENASYS TCH 300ML CANISTER / 66801273; RENASYS TCH 300ML CANISTER / 66801273; RENASYS TCH 300ML CANISTER / 66801273