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

Model Number 6379

Device Problem Temperature Problem (3022)

Patient Problem No Patient Involvement (2645)

Event Date 12/16/2014

Event Type  malfunction  

Event Description

The field service representative (fsr) reported that during preventive maintenance (pm) of the device, he noted a burning smell coming from the control module of the centrifugal system.There was no patient involvement.

Manufacturer Narrative

The fsr could not find the source the burning smell was coming from.The fsr replaced the control module and performed preventive maintenance (pm).The unit operated to manufacturer specifications and was returned to clinical use.

• 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: 4402975
• MDR Text Key: 5121288
• Report Number: 1828100-2014-01144
• 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: 12/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 6379
• Device Catalogue Number: 6379
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/16/2014
• 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