MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG 2ND GENERATION PRIMARY CONSOLE

Model Number 201-30300

Device Problems Overheating of Device (1437); Pumping Stopped (1503); Noise, Audible (3273)

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

Event Date 07/12/2018

Event Type  Injury  

Manufacturer Narrative

This medwatch is reporting the primary console.The motor is reported under medwatch mfr report # 2916596-2018-02840.The device was 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

It was reported that after 10 days of use in an extracorporeal membrane oxygenation (ecmo) circuit, the motor started making a loud noise.Immediately, it started to heat up and became very hot.An m6 alarm appeared on the display.The motor and primary console subsequently exchanged.The device was always working at the set revolutions per minute (rpm).There was no adverse consequence to the patient.No additional information was provided.

Manufacturer Narrative

Manufacturer's investigation conclusions: analysis of the log file provided by the account confirmed the reported m6 alarm; however, a root cause could not conclusively be determined through this evaluation.The returned motor operated as intended.After receipt, the returned motor and console passed initial inspection, and both units were cleaned and disinfected according to procedure.Visual inspection of the returned console did not show any obvious defects.An in-house blood pump was connected to a test loop and was inserted into the returned motor.Afterwards, the motor and in in-house flow probe were connected to the returned console.In order to read out the motor parameters during operation, desco software test bench was connected to the pcb of the returned console.The customer described a ¿high temperature¿ and loud noise coming from the motor.The cause for high temperature in a high bearing or drive current, which causes high copper loss in the windings.Due to this, the current values were recorded.The motor was operating at 1500 rpm and 3 lpm for 48 hours.During this time, the console operated as intended and passed all tests.All measured parameters were in the specified range.Although a root cause for the reported event could not be determined, 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) 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.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG 2ND GENERATION PRIMARY CONSOLE
• Type of Device: PRIMARY CONSOLE
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• MDR Report Key: 7993273
• MDR Text Key: 126116403
• Report Number: 2916596-2018-04626
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 07/10/2019

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: 201-30300
• Device Catalogue Number: 201-30300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/04/2018
• Initial Date FDA Received: 10/22/2018
• Supplement Dates Manufacturer Received: 06/28/2019
• Supplement Dates FDA Received: 07/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1