MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH THORATEC CENTRIMAG MOTOR

Catalog Number 102956

Device Problem Device Stops Intermittently (1599)

Patient Problem Neurological Deficit/Dysfunction (1982)

Event Date 03/19/2017

Event Type  Injury  

Manufacturer Narrative

Device unique identifier (udi) ¿ 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 4 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 (ecmo).A system fault alarm occurred, and the pump speed reportedly dropped to zero.It was reported that the unit ¿stopped working¿, and the speed read --- the flow read 0.0 lpm, and the read out below said ¿system failure¿.The cannulas, lines, power cords, and pump placement were checked.The console was power cycled, and device operation continued.The patient had no blood flow and decreased blood pressure for 2-3 minutes.The unit worked properly after restarting.The hospital clinicians were unable to wake the patient, and the patient had decreased neurological response.The patient was off sedation for approximately 24 hours.The console continued to operate the device as expected; however, during the transfer of the patient to the transport stretcher, it was reported that the exact same system failure happened with all the steps repeated above.During this second episode, the console would not restart, and continued to read ¿system failure¿.The console was exchanged to a backup console.It was reported that the exchange took 3-4 minutes, with no blood flow and decreased blood pressure.The hospital clinicians were unable to wake the patient, and the patient had decreased neurological response.The patient was off sedation for approximately 24 hours.No further additional was provided.

Manufacturer Narrative

The motor is not a single use device.Approximate age of the device is 8 years and 7 months; calculated from the manufacture date of the motor device analysis: the motor and primary console were returned for analysis.The primary console was inspected for external damage and no damage was observed.The primary console was connected to the returned motor and the devices were functionally tested together using laboratory equipment.No fault was initially observed; however, when the motor cable was manipulated during the testing, the reported ¿system fault¿ was able to be reproduced.Bending of the motor cable during testing caused the motor to intermittently produce a short circuit from motor phase ¿a¿ to the chassis/ground outer shield of the cable.The investigation could not determine a point in time when the intermittent short circuit on the motor cable occurred; however a possible root cause for the short circuit could have been aging and/or mechanical stress during handling.The motor has been in use in the field for 8 years, 7 months.A review of the device history record revealed no deviations from manufacturing or quality assurance specifications.No further information is available.The manufacturer is closing the file on this event.

• Brand Name: THORATEC CENTRIMAG MOTOR
• Type of Device: CENTRIMAG MOTOR
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; ch-8005 zurich CA ; SZ
• Manufacturer (Section G): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; ch-8005 zurich CA ; SZ
• Manufacturer Contact: kathy reilly ; 6101 stoneridge dr.; pleasanton, CA 94588 ; 9257380163
• MDR Report Key: 6494306
• MDR Text Key: 72847849
• Report Number: 2916596-2017-00738
• 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: Initial,Followup
• Report Date: 11/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 102956
• Device Lot Number: L00289-0001
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/19/2017
• Initial Date FDA Received: 04/14/2017
• Supplement Dates Manufacturer Received: 11/02/2017
• Supplement Dates FDA Received: 11/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2008
• 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): Hospitalization; Required Intervention