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

Catalog Number 66021496

Device Problems Fluid/Blood Leak (1250); Suction Failure (4039)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/25/2020

Event Type  malfunction  

Manufacturer Narrative

The device, was used in treatment was returned for evaluation, establishing a relationship between the event reported and the device. visual inspection of the device noted cracked casing. functional evaluation revealed that the device failed the pressure test with low vacuum alarm.The root cause is determined to be a faulty pump. the manufacturing records show no evidence that the product did not meet the specification at the time of manufacture.A complaint history review found other related failures. there were no indications that would suggest that the device did not meet product specifications upon release into distribution. smith and nephew will continue to monitor for any adverse trends relating to this product.

Event Description

It was reported that the nurse stated renasys go was alarming air leak.She stated she changed out the dressing twice.Instructed nurse to disconnect the orange connector however alarm did not resolve.No further information available.After investigation it was noticed that the device failed the pressure test with low vacuum alarm.

• Brand Name: RENASYS GO
• 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: 11531765
• MDR Text Key: 241357590
• Report Number: 8043484-2021-00655
• Device Sequence Number: 1
• Product Code: OMP
• UDI-Device Identifier: 05000223491000
• UDI-Public: 5000223491000
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152163
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 66021496
• Date Manufacturer Received: 03/16/2021
• 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: Unknown
• Patient Sequence Number: 1