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

Model Number 201-10002

Device Problems Overheating of Device (1437); Device Stops Intermittently (1599); Noise, Audible (3273)

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

Event Date 04/16/2018

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for analysis.It has not yet been received.The event occurred at (b)(6) hospital.No further information was provided.A supplemental report will be submitted when the.

Event Description

The patient was placed on biventricular extracorporeal membrane oxygenation (ecmo) support.It was reported that on (b)(6) 2018, the lvad started making a noise ¿as if it had air in it¿ and was hot to the touch.The battery alarm sounded and was silenced.The primary console alarmed immediately afterwards with an m4 alarm.The pump flows and revolutions per minute (rpm) were confirmed to be working.The patient was returned to the icu to change to the backup motor and primary console.The alarm was still sounding but the primary console showed rpms and power.While discussing the plan of action, the motor became quiet and completely stopped.The motor and primary console were quickly changed to the backup units.The whole event took approximately 2 minutes.It was reported that the patient was not injured due to the event.No additional information was provided.

Manufacturer Narrative

The report of a battery and m4 alarms, as well as of a hot motor, could not be confirmed nor reproduced during testing of the returned motor.During testing, the motor did not trigger any error messages nor did it make any abnormal sounds.No issues were found.The motor cable was inspected and no cable issues were found.Full functional checkout was performed and the motor passed all tests.Reports of similar events will continue to be tracked and monitored.Although the root cause of the reported event could not be conclusively determined, based on previous complaint experience, similar reports of pump noise issues, m4 alarms, and overheating motor/pumps has been a result of a centrimag pump being incorrectly installed inside of the motor receptacle.Centrimag motor instructions for use states that the blood pump must be fully seated into the receptacle to function properly.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG MOTOR, OUS
• Type of Device: MOTOR
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• MDR Report Key: 7577512
• MDR Text Key: 110345417
• Report Number: 2916596-2018-02217
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 12/10/2018

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: 201-10002
• Device Catalogue Number: 201-10002
• Other Device ID Number: 07640135140061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/17/2018
• Initial Date FDA Received: 06/07/2018
• Supplement Dates Manufacturer Received: 11/21/2018
• Supplement Dates FDA Received: 12/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1