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

Model Number 16404

Device Problem Protective Measures Problem (3015)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/13/2014

Event Type  malfunction  

Event Description

It was reported that during priming of the device for a cardiopulmonary bypass procedure, the air bubble detector (abd) system failed.The device was not changed out, as the surgical team turned off the abd and managed the surgery without the abd.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the pt.

Manufacturer Narrative

This complaint is related to mdr # 1828100-2014-01119.Confirmation that the subsidiary distributor service group originally thought the problem was due to the ultrasonic air sensors (uas).Troubleshooting summary by the subsidiary distributor found the air detector interface board of the safety monitor was defective.

• 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: 4366123
• MDR Text Key: 5265843
• Report Number: 1828100-2014-01120
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: NP
• PMA/PMN Number: K915183
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/08/2014

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: 16404
• Device Catalogue Number: 16404
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2014
• Initial Date FDA Received: 12/22/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/01/2003
• 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