MAUDE Adverse Event Report: THORATEC CORPORATION THORATEC CENTRIMAG PRIMARY CONSOLE

Catalog Number 102954

Device Problems Failure To Run On AC/DC (1001); Other (for use when an appropriate device code cannot be identified) (2203)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 09/11/2014

Event Type  malfunction  

Event Description

The patient was being supported with a ventricular assist device for acute support.It was reported that the flow and battery display on the primary console began to fluctuate while in use on the patient.It was reported that the primary console was in use for approximately 10 minutes prior to being exchanged.The primary console was found to not recognize ac power.No alarms were reported for the event.The patient was not injured during the event and there were no further issues after the primary console was exchanged.

Manufacturer Narrative

Patient information: information was requested but not provided.Approximate age of device: 7 years and 7 months.The primary console was returned for evaluation and the reported event was confirmed.When the returned unit was switched on, it did not start up and the display remained dark, independent of whether the unit was connected to the mains power supply.The power supply printed circuit board (pcb) was determined to be defective.The defective power supply pcb was replaced with a new one and after the replacement, the primary console operated on ac power as intended.A review of the device history records showed no deviations from manufacturing or qa specification that would affect device function or performance.No further information is available.The manufacturer is closing its file on this event.

Manufacturer Narrative

It was noted that the patient and device codes were inadvertently omitted from the initial medwatch report.No further information is available.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: 4372624
• MDR Text Key: 5288562
• Report Number: 2916596-2014-02329
• 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: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/02/2014

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: 09/22/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/02/2014
• Initial Date FDA Received: 12/30/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/31/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/30/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1