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

Model Number 201-10003

Device Problems Mechanical Problem (1384); Smoking (1585)

Patient Problems Heart Failure (2206); Respiratory Failure (2484)

Event Date 07/08/2016

Event Type  Injury  

Manufacturer Narrative

The initial submission of this event was reported by the manufacturer under mfr.Report # 2916596-2016-01491.Patient information was not provided.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 in conjunction with extracorporeal membrane oxygenation on (b)(6) 2016.It was reported that a short time after bedside ecmo cannulation, the bedside nurses smelled smoke, at which time the console shut down and the speed went to zero.The patient immediately decompensated with desaturation and hypotension.The nurses emergently clamped the circuit and switched to the backup console and motor.The circuit was switched to a 2nd generation circuit system.The patient immediately stabilized once flow was initiated.It was reported that no alarms were noted at the time of the incident.

• Brand Name: CENTRIMAG MOTOR, US
• 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: 7774373
• MDR Text Key: 116857151
• Report Number: 2916596-2018-03429
• 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: health professional
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 12/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 201-10003
• Device Catalogue Number: 201-10003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/15/2018
• 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
• Removal/Correction Number: Z-0103-2019
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 20 YR