MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH THORATEC CENTRIMAG MOTOR

Catalog Number 201-10002

Device Problem Device Stops Intermittently (1599)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 01/27/2017

Event Type  Injury  

Manufacturer Narrative

The patient's age, gender and weight were not provided.Device unique identifier (udi) ¿ device was manufactured prior to the udi labeling implementation.The motor is not a single use device.Approximate age of the device is 13 years and 3 months (calculated from the manufacture date of the motor).The devices were returned for investigation.The evaluation is not yet complete.The event occurred at (b)(6).No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is complete.

Event Description

The patient was placed on extracorporeal circulatory support.It was reported that during extracorporeal membrane oxygenation (ecmo) support, a "motor disconnected" message was displayed on the primary console and pump stoppage occurred.The motor and primary console were exchanged and ecmo support resumed as expected.No additional information was provided.

Manufacturer Narrative

Concomitant products: primary console s/n (b)(4), manufacture date 03/01/2004; adult flow probe s/n (b)(4), manufacture date 03/01/2004.Device evaluation: the returned motor was functionally tested together along with the returned primary console and flow probe.When the returned motor was connected to the returned primary console, a "motor disconnected" message was displayed on the primary console.Further analysis revealed that the returned motor was responsible for the event.Impedance measurements indicated that there was an intermittent short circuit in one of the motor phase lines.The specific point in time in which this short circuit condition came into existence could not be determined through the evaluation.The suspected cable break could be due to a combination of aging and mechanical stress during handling.Review of the device history records revealed that all three devices were 13 years of age, which exceeds their expected life time of 10 years.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 MOTOR
• Type of Device: CENTRIMAG MOTOR
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zürich CH-80 05; SZ CH-8005
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; technoparkstrasse 1; pleasanton CA 94588
• Manufacturer Contact: kathy reilly ; 6101 stoneridge dr.; pleasanton, CA 94588 ; 9257380163
• MDR Report Key: 6401162
• MDR Text Key: 69823549
• Report Number: 2916596-2017-00517
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 201-10002
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2003
• 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
• Treatment: PRIMARY CONSOLE S/N (B)(4), MFR DATE 03/01/2004
• Patient Outcome(s): Hospitalization; Required Intervention