MAUDE Adverse Event Report: THERMEDX, LLC THERMEDX FLUIDSMART SYSTEM; FLUID MANAGEMENT SYSTEM

Model Number 37-5

Device Problems Improper or Incorrect Procedure or Method (2017); Device Operates Differently Than Expected (2913); No Fail-Safe Mechanism (2990)

Patient Problems Rupture (2208); Respiratory Failure (2484)

Event Date 11/11/2016

Event Type  Injury  

Event Description

A (b)(6) male underwent an elective cystoscopy with transurethral resection of left posterior lateral bladder tumor and resection of bladder neck papillary tumor on (b)(6) 2016.The procedure was done for recurrent bladder cancer.The fluid warmer (thermedx fluidsmart system) was being used for the first time in the hospital's operating room and was operated by the vendor during the procedure.Air bubbles were noted on the cystoscopy screen during the procedure and the pressure was increased from 60 mmhg to 70 mmhg to help eliminate the bubbles.A total of 12,210 ml of ns was pumped in during the procedure.The pt became bradycardic and hypotensive during the procedure and was treated with ephedrine with adequate response.Upon arrival in the recovery room, the pt awoke in extreme pain and was noted to have a rigid, distended abdomen.Additionally, he had a declining respiratory status which required reintubation.A stat abdominal ct revealed the presence of free fluid and free air in the abdomen and pelvis secondary to perforation in the left anterior aspect of the bladder.

• Brand Name: THERMEDX FLUIDSMART SYSTEM
• Type of Device: FLUID MANAGEMENT SYSTEM
• Manufacturer (Section D): THERMEDX, LLC; solon OH 44139
• MDR Report Key: 6132407
• MDR Text Key: 61105784
• Report Number: 6132407
• Device Sequence Number: 1
• Product Code: LGZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 37-5
• Device Catalogue Number: P2000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/11/2016
• Event Location: Hospital
• Date Report to Manufacturer: 11/22/2016
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention
• Patient Age: 70 YR
• Patient Weight: 71