MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. TERUMO PERFUSION SYSTEM 8000; 8K (ROLLER PUMP)

Model Number 16402

Device Problems Increased Pump Speed (1501); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/03/2014

Event Type  malfunction  

Event Description

It was reported that during use of the device for a cardiopulmonary bypass procedure, the roller pump display showed "over speed 3." the device was not changed out, as they did not use the pump.The surgical procedure was completed successfully, and there were no delays, no blood loss or no adverse consequences to the patient.Per the clinical review on (b)(6) 2014: during cardiopulmonary bypass the roller pump used for arterial blood flow stopped and the message "ovrspd3" was displayed on the pump.This is an indication the pump detected an over speed condition and automatically stops the pump.The pump was not able to be re-started.The perfusionist hand cranked for about 30 seconds and then elected to remove the pump from the base and replace with a spare pump on the base.Tubing was removed from the stopped pump and the pump was taken off the base.The spare was connected to the base and the tubing was placed in the pump raceway.The pump was started and the roller occlusion was adjusted while the pump was rotating.According to the ccp, there was no arterial flow for about 30-45 seconds.There were no issues the remainder of the procedure.The patient was weaned from cpb without issue and the case was completed, as scheduled.There was no associated loss of blood and there was no actual delay in the surgical procedure as this issue was being mitigated.There was no patient harm observed or reported.

• Brand Name: TERUMO PERFUSION SYSTEM 8000
• Type of Device: 8K (ROLLER PUMP)
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP.; ann arbor MI 48103
• Manufacturer Contact: jan winder ; 6200 jackson rd.; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 3786214
• MDR Text Key: 4377405
• Report Number: 1828100-2014-00098
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K953901
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 16402
• Device Catalogue Number: 16402
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/03/2014
• Initial Date FDA Received: 02/26/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/01/2001
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention