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

Model Number 16422

Device Problems Failure to Run on Battery (1466); Power Problem (3010)

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

Event Date 06/03/2014

Event Type  malfunction  

Event Description

It was reported that during set-up of the device for a cardiopulmonary bypass procedure, the battery light was blinking red on the perfusion system's battery module.When the system was unplugged, it went dead.As a result, as alternate system was employed.The surgical procedure was completed successfully.There were no delays, no blood loss, or no adverse consequences to the pt.

• Brand Name: TERUMO PERFUSION SYSTEM 8000
• Type of Device: 8K
• 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: 3966257
• MDR Text Key: 16544301
• Report Number: 1828100-2014-00524
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K915183
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 06/03/2014

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
• Device Operator: Health Professional
• Device Model Number: 16422
• Device Catalogue Number: 16422
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/03/2014
• Initial Date FDA Received: 06/25/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/01/2006
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1