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

Model Number 9490

Device Problem Battery Problem (2885)

Patient Problem No Patient Involvement (2645)

Event Date 12/19/2013

Event Type  malfunction  

Event Description

It was reported by the field service representative (fsr) while visiting the user facility for another issue, it was discovered that the centrifugal back-up batteries dead.There was no pt involvement.

Manufacturer Narrative

This complaint is related to mdr #1828100-2013-01176 and 1828100-2013-01178.The user facility moved into a new facility, the perfusion systems were unplugged and moved.No one plugged in the systems or turned them on to keep a charge on the batteries.

• 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 ; 7346634145
• MDR Report Key: 3647585
• MDR Text Key: 4183063
• Report Number: 1828100-2013-01179
• 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: Not Applicable
• Type of Report: Initial
• Report Date: 12/19/2013

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: 9490
• Device Catalogue Number: 9490
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/19/2013
• Initial Date FDA Received: 01/09/2014
• 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