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

Catalog Number 201-10002

Device Problems Mechanical Problem (1384); Pumping Stopped (1503)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 11/13/2015

Event Type  malfunction  

Manufacturer Narrative

The initial submission of this event was reported by the manufacturer under mfr.Report # 2916596-2016-00258.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 8 years and 10 months; calculated from the manufacture date of the motor.The device returned for analysis.The complaint investigation determined the reported difficulty was the result of a design related wear issue.After review of this event and similar incidents, abbott has decided to initiate a voluntary field action for centrimag.Abbott performed a comprehensive investigation which included device analysis, manufacturing evaluation and trend analysis.

Event Description

The patient was placed on an extracorporeal circulatory support device for extracorporeal membrane oxygenation on (b)(6) 2015.On the same day, during patient transport, it was reported that a motor fault error occurred.A review of the device log files found that pumping had stopped during the event.After switching to the backup centrimag motor, the system functioned properly.The patient experienced unspecified symptoms, but reportedly was not harmed during the event.As of 10dec2015, the patient status had improved and the patient had been discharged back to the care of the referring hospital.No additional information was provided.

• Brand Name: CENTRIMAG MOTOR, OUS
• Type of Device: MOTOR
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• Manufacturer (Section G): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• Manufacturer Contact: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 7774640
• MDR Text Key: 117019773
• Report Number: 2916596-2018-03366
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 08/10/2018

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2015
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/13/2018
• Initial Date FDA Received: 08/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 1 DA