MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH THORATEC CENTRIMAG MOTOR

Catalog Number 201-10002

Device Problem No Display/Image (1183)

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

Event Date 05/14/2017

Event Type  Injury  

Manufacturer Narrative

The patient¿s weight was not provided.(b)(6).Concomitant products: primary console: serial number (b)(4), manufacture date: 04/09/2013; flow probe: serial number (b)(4), manufacture date: 02/01/2015.The motor is not a single use device.Approximate age of the device is 2 years, 3 months (calculated from the manufacture date of the motor).The devices are expected to be returned for analysis.They have not yet been received.The event occurred at (b)(6).No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

The patient was placed on biventricular extracorporeal circulatory support on (b)(6) 2017.It was reported that on (b)(6) 2017, the system indicated that there was no flow, although the pump head was rotating.It was reported that the patient had flow and pressure throughout the event, even though the primary console displayed no flow.Reportedly, the patient was not injured due to the event.The flow probe, motor, and primary console were exchanged for backup units.The patient remains on biventricular support awaiting transplant.No additional information was provided.

Manufacturer Narrative

Device evaluation: the report of no flow readings could not be confirmed as the events that occurred on (b)(6)2017 had been overwritten in the log file of the returned primary console.The log file entries began on (b)(6) 2017 and showed the system operating continuously until (b)(6) 2017, when the system was manually stopped by the user.Additionally, the reported issue could not be reproduced during the investigation and testing of the returned devices.The motor, primary console, and flow probe were tested at the same working points as they were seen in the log file for two days and no problem or fault occurred.The returned devices operated as intended throughout the investigation and the root cause of the reported no flow issue could not be conclusively determined.A review of the device history records revealed that the device met applicable specifications.No further information was provided.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; pleasanton CA 94588
• Manufacturer Contact: kathy reilly ; 6101 stoneridge dr.; technoparkstrasse 1; pleasanton, CA 94588 ; 9257380163
• MDR Report Key: 6605712
• MDR Text Key: 76444326
• Report Number: 2916596-2017-01150
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 10/27/2017

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?: 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: 06/23/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/15/2017
• Initial Date FDA Received: 06/01/2017
• Supplement Dates Manufacturer Received: 09/27/2017
• Supplement Dates FDA Received: 10/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2015
• 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
• Patient Age: 32 YR