MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG MOTOR; MOTOR, RENTAL

Model Number L102956

Device Problem Excessive Heating (4030)

Patient Problem No Patient Involvement (2645)

Event Date 06/14/2019

Event Type  Injury  

Manufacturer Narrative

No patient was involved.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

It was reported that the centrimag (cmag) motor was hot to touch and was not on a patient.

Event Description

Additional information: the site stated that the cause of motor being hot was due to poor ventilation around the pump.Device will not be returned for evaluation.

Manufacturer Narrative

Section g1: correction.Section h4: additional information.Manufacturer's investigation conclusion: the reported event of the motor being hot to the touch was not confirmed.The centrimag motor (serial #: (b)(6)) was not returned for analysis.No log files were submitted for review.The root cause for the motor being hot to the touch was not conclusively determined through this analysis; however, additional provided information indicated that the reported event was caused by poor ventilation around the pump.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG MOTOR
• Type of Device: MOTOR, RENTAL
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• MDR Report Key: 8754098
• MDR Text Key: 149819465
• Report Number: 2916596-2019-02906
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 07640135140078
• UDI-Public: 07640135140078
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/11/2019

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: L102956
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/14/2019
• Initial Date FDA Received: 07/02/2019
• Supplement Dates Manufacturer Received: 07/08/2019; 09/09/2019
• Supplement Dates FDA Received: 07/10/2019; 09/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1