MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG MOTOR, US

Catalog Number 102956

Device Problem Defective Alarm (1014)

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

Event Date 08/14/2018

Event Type  malfunction  

Manufacturer Narrative

Information was not provided.Serial number of the motor was not provided.The motor is a single use device.No further information is available at this time.A supplemental report will be submitted with the manufacture investigation is completed.

Event Description

The patient was implanted with an extracorporeal circulatory support pump.It was reported that 20 minutes after initiating extracorporeal-membrane-oxygenation (ecmo) support, the centrimag primary console alarmed with s3, system alert.The customer was instructed to acknowledge the alarm, but the alarm did not resolve.The customer exchanged the pump head to the back up console.The patient was fine after the exchange.No additional information was provided.

Manufacturer Narrative

Device mfr date: additional information.Manufacturer's investigation conclusion: the returned motor was evaluated and tested and the reported issue could not be duplicated during testing.The motor cable was inspected and no issues were observed.The motor was tested with the 2nd gen primary console associated with the complaint.The motor did not give any error messages and no alarms were observed.The test ran successfully with the correct flow and speeds at all times.A full functional checkout was performed per the centrimag motor service process and the motor passed all tests, functioning as designed during testing.The tested motor was returned to the customer site.A review of the device history records revealed the device met applicable specifications.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG MOTOR, US
• Type of Device: CENTRIMAG MOTOR
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• MDR Report Key: 7839257
• MDR Text Key: 119040912
• Report Number: 2916596-2018-03880
• 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
• Type of Report: Initial,Followup
• Report Date: 01/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 102956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1