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

Model Number 801046

Device Problem No Display/Image (1183)

Patient Problem No Patient Involvement (2645)

Event Date 12/14/2013

Event Type  malfunction  

Event Description

The service repair technician (srt) reported that during routine testing of the device at the service center, the centrifugal control module display was partially blank on the centrifugal system.There was no patient involvement.

Manufacturer Narrative

Visual inspection by the service repair technician (srt) revealed cracks in crystal display.

• Brand Name: TERUMO CENTRIFUGAL SYSTEM
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP.; ann arbor MI 48103
• Manufacturer Contact: jan winder ; 6200 jackson rd.; ann arbor, MI 48103
• MDR Report Key: 3697982
• MDR Text Key: 4228385
• Report Number: 1828100-2013-01161
• 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: Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 12/14/2013

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: Other
• Device Model Number: 801046
• Device Catalogue Number: 801046
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/14/2013
• Initial Date FDA Received: 01/08/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/01/2002
• 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