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

Catalog Number 102956

Device Problem Mechanical Problem (1384)

Patient Problem Neurological Deficit/Dysfunction (1982)

Event Date 03/19/2017

Event Type  Injury  

Manufacturer Narrative

The initial submission of this event was reported by the manufacturer under mfr report # 2916596-2017-00738.This report is being submitted as additional information.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 supported by an extracorporeal circulatory support device (ecmo).A system fault alarm occurred, and the pump speed reportedly dropped to zero.It was reported that the unit ¿stopped working¿, and the speed read --- the flow read 0.0 lpm, and the read out below said ¿system failure¿.The cannulas, lines, power cords, and pump placement were checked.The console was power cycled, and device operation continued.The patient had no blood flow and decreased blood pressure for 2-3 minutes.The unit worked properly after restarting.The hospital clinicians were unable to wake the patient, and the patient had decreased neurological response.The patient was off sedation for approximately 24 hours.The console continued to operate the device as expected; however, during the transfer of the patient to the transport stretcher, it was reported that the exact same system failure happened with all the steps repeated above.During this second episode, the console would not restart, and continued to read ¿system failure¿.The console was exchanged to a backup console.It was reported that the exchange took 3-4 minutes, with no blood flow and decreased blood pressure.The hospital clinicians were unable to wake the patient, and the patient had decreased neurological response.The patient was off sedation for approximately 24 hours.No further additional was provided.

• 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
• 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: 7775172
• MDR Text Key: 116858137
• Report Number: 2916596-2018-03373
• 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: company representative,health
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 08/11/2018

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: 102956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/13/2018
• Initial Date FDA Received: 08/11/2018
• 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): Hospitalization; Required Intervention