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

Catalog Number 102954

Device Problems Smoking (1585); Device Stops Intermittently (1599)

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

Event Date 08/30/2017

Event Type  malfunction  

Manufacturer Narrative

The patent's age, sex, and weight were not provided.Device was manufactured prior to the udi labeling implementation.Approximate age of device - the primary console is not a single use device.Approximate age of the device from the manufacturer date is 7 years and 6 months.The device was returned for investigation.The evaluation is not yet complete.No additional information was provided.A supplemental report will be submitted when the manufacturer's investigation is completed.

Event Description

The patient was supported by an extracorporeal circulatory support device.It was reported that the primary console began to smell of smoke while connected to the patient.The system console failure alarm occurred with --- and 0.00 noted on the speed and flow meters, respectively.The blood circuit and pump were transferred to the backup console and the alarm recolved.It was also reported that the motor required elevated power levels.There was no adverse patient impact reported for this event.No additional information was provided.

Manufacturer Narrative

The report of "smell of smoke coming from the console" was confirmed and reproduced during testing of the returned primary console.The returned console was connected to a/c power and powered on.The unit began the boot-up process but restarted soon after.The unit then continued a sequence of booting-up followed by a restart.After a few minutes a burning smell was noted followed by smoke from the device, reproducing the reported event.The console was disassembled and inspection of the internal components revealed a damaged (burned) power switch (component u200).The impedance measured across the component revealed that the component was shorted.The root cause of the damaged component could not be conclusively determined during the investigation.However, it is possible that the damage could have been caused by a defective motor or motor cable.No additional devices used at the time of the reported event were returned for analysis.As a result, a motor or motor cable related issue could not be confirmed during the investigation.Reports of similar events will continue to be tracked and monitored.A review of the device history records revealed no deviations from manufacturing or quality assurance 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 SWITZERLAND GMBH; technoparkstrasse 1; ch-8005 zurich ; SZ
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer Contact: bob fryc ; 6101 stoneridge dr.; pleasanton, CA 94588 ; 7818528390
• MDR Report Key: 6894960
• MDR Text Key: 89399470
• Report Number: 2916596-2017-02145
• 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
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 05/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2017
• Is this an Adverse Event Report?: Yes
• 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: 09/05/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2010
• 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 Outcome(s): Required Intervention