MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. RENASYS TCH DEVICE&POWER SPLY; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Model Number 66801280

Device Problems Defective Alarm (1014); Fluid/Blood Leak (1250)

Patient Problems Impaired Healing (2378); Tissue Breakdown (2681); Skin Disorders (4543)

Event Date 11/10/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference case- (b)(4).

Event Description

It was reported that, during npwt, a renasys touch device&power supply never alarmed to show a leak, and when examined, the foot was macerated.The patient was admitted into the hospital, has started antibiotics, and is currently not on the pump, so treatment was suspended.

Manufacturer Narrative

H10: additional information the device was returned for evaluation, with no faults found, we cannot confirm the reported event.A visual and functional evaluation confirmed no defects, the device displayed the appropriate alarms under expected conditions the instruction for use detail, carefully and frequently monitor the patient, device, and dressing frequently to determine if there are any signs of bleeding, exudate accumulation (pooling), infection, maceration, or loss of negative pressure wound therapy.The frequency should be determined by the clinician based on individual characteristics of the patient and wound medical review concluded, this case reports that the renasys npwt device failed to alarm causing maceration.It was communicated via e-mail that there was pooling of fluid under the planter of the foot however no alarm had alerted them, and ¿that this may be a result that the device was switched off for half an hour prior to inspection which would be common practice for ease of removal of foam.¿ the device was returned and passed all testing during the functional evaluation.Based on the information provided and the results of the functional evaluation we are currently unable to rule out a procedural variance as a contributing factor to the reported event, which does not represent a device malfunction.It was also communicated that the ¿patient is presently in hospital on antibiotics and had further debridement.¿ this event is considered ongoing.No further clinical/medical assessment is warranted at this time.Should additional clinical documentation become available in the future, the clinical/medical task may be re-evaluated.A documentation review has been conducted, confirming the device no manufacturing defects, complaint history has recorded previous occurrences of this nature.The instructions for use contain comprehensive instructions on the safe operation and use of the device.The risk files mitigate the reported issue with no updates required.Smith and nephew can confirm the device met manufacturing specifications upon release for distribution and continue to monitor for adverse trends relating to this product range.This investigation is now complete, confirming the event is not related to a manufacturing problem and that no corrective actions are deemed necessary.

Event Description

It was reported that, during npwt, a renasys touch device&power supply never alarmed to show a leak, and when examined, the foot was macerated.The advanced nurse practitioner reported that there was a pooling of fluid under the planter of the foot however no alarm had alerted them that there was a leak.The drape was still intact however fluid had built up underneath.The patient was admitted into the hospital, has started antibiotics, and is currently not on the pump, so treatment was suspended.Patient had further debridement, and had used aquacel on the periwound before applying duoderm.

• Brand Name: RENASYS TCH DEVICE&POWER SPLY
• 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
• Manufacturer (Section G): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12878176
• MDR Text Key: 281276887
• Report Number: 8043484-2021-01980
• Device Sequence Number: 1
• Product Code: OMP
• UDI-Device Identifier: 00040565126586
• UDI-Public: 00040565126586
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K153209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 66801280
• Device Catalogue Number: 66801280
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1