MAUDE Adverse Event Report: THORATEC CORPORATION THORATEC CENTRIMAG PRIMARY CONSOLE

Catalog Number 102954

Device Problem Smoking (1585)

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

Event Date 10/09/2015

Event Type  malfunction  

Manufacturer Narrative

Device unique identifier (udi) - device was manufactured prior to udi labeling implementation.Approximate age of device - the centrimag primary console is not a single use device.Approximate age of the device from the manufacture date is 5 years and 10 months.The device is expected to be returned for evaluation.It has not yet been received.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

The patient is supported by an extracorporeal circulatory support device.It was reported that the primary console emitted smoke and a burning smell while in use.The primary console was exchanged with no issues.The patient was asymptomatic.

Manufacturer Narrative

The primary console was returned for evaluation.When the console was switched on using the mains power supply the unit did not start-up as intended and the reported smell of smoke was reproduced.During visual inspection of the internal printed circuit boards (pcb), it was found that one power switch on the motor controller board showed evidence of a short circuit event.The power switch appeared to be appropriately seated at the heat sink and nothing atypical was noted during visual inspection of the switch or the pcb itself.Additionally, no damage was found with any of the internal cables.The motor controller board was replaced and the primary console then passed all testing.The root cause for the reported event could not be conclusively determined.However, based on the manufacturer¿s previous experience, the root cause was possibly a short circuit produced by the motor (motor cable), which was connected to the primary console at the time of the event.A short circuit inside of the motor connector/cable may have damaged the motor controller printed circuit board inside of the returned primary console.The customer was contacted with a request to return the suspect centrimag motor.The perfusionist reported that the serial numbers of the centrimag motors are not recorded at the time of use as the motors are exchanged frequently during an extracorporeal support run.The centrimag motors are multiple use devices.The serial number for the motor used in this event remains unknown.A review of the device history records for the primary console revealed the device met applicable specifications.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: THORATEC CENTRIMAG PRIMARY CONSOLE
• Type of Device: CENTRIMAG PRIMARY CONSOLE
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer Contact: robert fryc ; 23 fourth avenue; burlington, MA 01803 ; 781272-013
• MDR Report Key: 5206363
• MDR Text Key: 30571186
• Report Number: 2916596-2015-02073
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/09/2015

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: Health Professional
• Device Catalogue Number: 102954
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/09/2015
• Initial Date FDA Received: 11/05/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Weight: 32