MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH THORATEC CENTRIMAG PRIMARY CONSOLE

Catalog Number 102954

Device Problems Decreased Pump Speed (1500); Infusion or Flow Problem (2964)

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

Event Date 08/21/2015

Event Type  malfunction  

Manufacturer Narrative

Device unique identifier (udi) - device was manufactured prior to udi labeling implementation.The centrimag primary console is not a single use device.Approximate age of the device from the manufacture date is 8 years and 11 months.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 biventricular extracorporeal circulatory support devices.It was reported that the device console emitted a puff of white smoke from the bottom of the unit and immediately alarmed while connected to the patient.The perfusion staff reportedly observed a reduction in speed along with a low flow alarm.The staff immediately unplugged the unit from ac power and switched the patient to a backup console without incident.The patient was not injured or symptomatic due to the event.

Manufacturer Narrative

During the evaluation of the console at the manufacturing site, a power switch on the motor controller printed circuit board (pcb) was found to be defective.Although a root cause for the reported event could not be conclusively determined, a temporary short circuit condition at the motor connector or cable would have caused damage to the motor controller pcb inside the returned console.The suspect motor was not returned for evaluation, however the user facility was informed about the potential motor defect.A review of the device history records revealed no deviations from manufacturing or quality assurance specifications.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 SWITZERLAND GMBH; technoparkstrasse 1; ch-8005 zurich ; SZ
• 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: 5086349
• MDR Text Key: 26112771
• Report Number: 2916596-2015-01717
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: Followup
• Report Date: 08/21/2015

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/17/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2006
• 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 Age: 67 YR
• Patient Weight: 74