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

Model Number 6379

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Not Applicable (3189)

Event Date 03/11/2014

Event Type  malfunction  

Event Description

It was reported that during the use of the device for a non-clinical activity, the user facility's biomedical engineer (biomed) was checking the control module for proper operation after having trouble yesterday.The biomed powered up the control module, it stopped, and displayed a "fail 4" error message.Further power up attempts were performed the unit worked correctly.Unit was not used for any cases.Stand alone unit so they are using another.There was no patient involvement.

Manufacturer Narrative

This complaint is related to mdr #1828100-2014-00222.

• Brand Name: TERUMO CENTRIFUGAL SYSTEM
• Type of Device: 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: 3853227
• MDR Text Key: 4407231
• Report Number: 1828100-2014-00223
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 03/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6379
• Device Catalogue Number: 6379
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/11/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/01/2011
• 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