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

Catalog Number 102956

Device Problem Overheating of Device (1437)

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

Event Date 12/18/2018

Event Type  Death  

Manufacturer Narrative

Gender was not provided.The motor is not a single use device.Approximate age of device - 14 days (calculated from the date the patient was placed on extracorporeal circulatory support).The devices that were exchanged during this event (motor, primary console, flow probe) have been returned for investigation.The evaluation is not yet complete.No further information was provided.A supplemental report will be submitted when the manufacturer's investigation is completed.

Event Description

The patient was placed on extracorporeal circulatory support on (b)(6) 2018.On (b)(6) 2018, the motor overheated which required the console, motor, and flow probe to be changed to the backup system.The patient was stable other than the momentary lapse in support due to the exchange.Support was resumed without any further problems.The patient expired on (b)(6) 2018.It was reported that death was not related to the device or therapy.No further information was provided.

Manufacturer Narrative

Additional information.Device evaluation: the reported event could not be confirmed through the evaluation of the returned centrimag motor and a root cause could not conclusively be determined through this evaluation.The returned centrimag motor was tested for an extended period of time with the returned console (serial number (b)(4) and flow probe (serial number (b)(4).There were no abnormal changes in temperature nor any other issues.The motor functioned as intended.The motor cable was inspected and no issues were found.A full functional checkout was performed and the unit passed all tests.The motor will be returned to the rental pool.Although the reported event could not be confirmed nor correlated to a device related issue, reports of similar events have been documented and based on previous complaint experience can be a result of a pump not being fully seated inside of the motor's pump receptacle.Centrimag motor instructions for use (ifu) (b)(4) states "the blood pump must be fully seated into the receptacle to function properly." this document also describes how the centrimag blood pump should be installed inside of the centrimag motor.Additionally, the centrimag system operating manual states that "the recommended practice whenever there is a 2nd generation centrimag primary console or motor malfunction is to replace the console and motor as a set.Remove the blood pump from the malfunctioning motor and console and place the blood pump in the backup motor and console to continue patient support." the reported event and subsequent investigation do not indicate an issue with the manufacture of the product.No further information was provided.The manufacturer is closing the file on the 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: 8225179
• MDR Text Key: 132339784
• Report Number: 2916596-2019-00021
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 05/02/2019

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: Lay User/Patient
• Device Catalogue Number: 102956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/18/2018
• Initial Date FDA Received: 01/08/2019
• Supplement Dates Manufacturer Received: 03/28/2019; 05/01/2019
• Supplement Dates FDA Received: 04/08/2019; 05/02/2019
• Patient Sequence Number: 1
• Treatment: FLOW PROBE, SERIAL # (B)(4). ; PRIMARY CONSOLE, SERIAL # (B)(4); FLOW PROBE, SERIAL # (B)(4); PRIMARY CONSOLE, SERIAL # (B)(4)
• Patient Outcome(s): Death; Life Threatening; Required Intervention
• Patient Age: 37 YR
• Patient Weight: 110