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

Model Number 102956

Device Problems Mechanical Problem (1384); Overheating of Device (1437); Decreased Pump Speed (1500); Pumping Stopped (1503)

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

Event Date 02/03/2015

Event Type  malfunction  

Manufacturer Narrative

The initial submission of this event was reported by the manufacturer under mfr.Report # 2916596-2015-00388.Device evaluation: the device returned for analysis.The returned motor was cleaned, disinfected, and connected to an in-house flow probe, mock circulatory loop, and in-house console.The console was then powered on and the motor speed was set to 3000 rpm with a flow rate of 5 lpm.As soon as the motor cable was moved, the in-house console sounded/displayed a set speed not reached alert, and the actual displayed motor speed value fluctuated below the set speed value.The returned motor was then disconnected and the motor and bearing phase impedances were measured using a multimeter while the motor cable was manipulated.The results of this testing showed that there were open circuits in the two motor phases and in bearing phase a, indicating that there was a cable break, possibly near the motor cable¿s exit site.The point in time when the cable break occurred and the root cause for its occurrence could not be conclusively determined; however, the cable break could be due to aging and/or mechanical stress during handling.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

This is report #3 of 3.Three centrimag motors were received by the manufacturer.No patient identification was provided, however, it was reported that the events involved two separate patients and three motors.One patient was reported to be on bi-ventricular circulatory support, one patient was on single (unspecified) ventricular circulatory support and one of the patients was additionally supported by extracorporeal membrane oxygenation, however it could not be confirmed which patient.One event occurred while the patient was in the operating room undergoing a mitral valve repair.It was reported that the primary consoles began to alarm with "motor overheat" and "unable to maintain set rpm's" and the pump motors subsequently shut down.The patients were reportedly asymptomatic.The pump motors and primary consoles were exchanged for the back-up devices and the patients continued on support.Attempts were made to obtain further information but to date, 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: 7774248
• MDR Text Key: 117019817
• Report Number: 2916596-2018-03437
• 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: company representative,health
• Reporter Occupation: Other Health Care 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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 102956
• Device Catalogue Number: 102956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2015
• 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: 08/10/2018
• 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