MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. TERUMO CENTRIFUGAL SYSTEM; SARNS CENTRIFUGAL SYSTEM

Model Number 6382

Device Problems Device Alarm System (1012); Device Displays Incorrect Message (2591)

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

Event Date 06/12/2014

Event Type  malfunction  

Event Description

It was reported that during set-up of the device for a cardiopulmonary bypass procedure, the customer was getting a "backflow" error with the flow sensor.As a result, an alternate device was employed.The surgical procedure was completed successfully.There were no delays, no blood loss, or no adverse consequences to the patient.

• Brand Name: TERUMO CENTRIFUGAL SYSTEM
• Type of Device: SARNS CENTRIFUGAL SYSTEM
• 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: 3979782
• MDR Text Key: 16184837
• Report Number: 1828100-2014-00561
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K950739
• 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: 06/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6382
• Device Catalogue Number: 6382
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/12/2014
• Was Device Evaluated by Manufacturer?: No
• 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