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

Catalog Number 102956

Device Problem Mechanical Problem (1384)

Patient Problem Dizziness (2194)

Event Date 01/04/2016

Event Type  Injury  

Manufacturer Narrative

The initial submission of this event was reported by the manufacturer under mfr.Report # 2916596-2016-00212.Patient information 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 supported with biventricular extracorporeal circulatory support devices.It was reported that the left ventricle pump motor overheated, causing the console to alarm on (b)(6) 2016 at approximately 10:40 pm.Flow values decreased to 0.47 lpm, the pump speed dropped to 0 rpm, the patient¿s mean arterial pressure decreased to 44 mmhg, and the patient complained of dizziness.The right ventricle pump flows and speed values were unchanged at this time.It was reported that the equipment was well ventilated at the time of the event and was not covered in blankets, pillows, etc.The intensive care unit staff physicians were informed immediately and arrived at the patient¿s bedside.The left ventricle backup console and backup motor were set up and turned on and the devices were switched out.After the switch occurred, it was reported that the flows on the both the right and left pumps became erratic with values down to 1.5-2 lpm and pump speeds between 2000-5000 rpm.The patient was reportedly ambu-bagged and started to have frothy and bloody pulmonary secretions.The patient was started on levophed, vasopressin and epinephrine for support.After a thorough investigation, it was found that the right and left consoles were switched during the equipment exchange (the right pump was at the left pump settings and vice versa).After proper speed adjustments, the flow values returned to 3-6 lpm and the patient became stable.The patient was reportedly alert and able to follow commands, but required vasopressors and additional inotropes for support.The patient was transferred to the cardiothoracic icu for close monitoring and the console and motor were returned for evaluation.No further information 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: 7770859
• MDR Text Key: 116746368
• Report Number: 2916596-2018-03408
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 07640135140078
• UDI-Public: 07640135140078
• 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: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 08/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 102956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/13/2018
• 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