MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG 2ND GENERATION PRIMARY CONSOLE WITH EM-TEC ADULT FLOW PROBE, OUS; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 201-90401

Device Problem Overheating of Device (1437)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/15/2019

Event Type  Injury  

Manufacturer Narrative

Manufacturer investigation conclusion: the reported event of a motor over temp alarm was not confirmed; however, a m4 alarm was confirmed.The centrimag 2nd generation primary console was returned for analysis at mcs (b)(4) and was investigated by investigator (b)(4).A log file was downloaded from the console for review.The log file did not show the reported m6 alarm; however, a m4 error was active on (b)(6) 2019 at 02:22, showing levitation problems in the pump: ¿sf_ifd_levitation¿.The returned console returned was tested with the returned and associated motor as well as a test monitor.The motor was run at a speed of 4400 rpm with a flow of 5 lpm.The system was able to operate at this speed from (b)(6) 2019 at 17:30 to (b)(6) 2019 at 10:45.No faults occurred during testing.During preparation for the electrical safety test, the console was connected to the motor again and an m4 alarm occurred.The log file was downloaded from the console to investigate these events.The downloaded log file showed a ¿sf_lmc_levitation¿.The pump did not even start running before this error had occurred.The console had been tested with a r&d lmcepbx lcb and no errors occurred.The original lmcebpx pcb was tested and the test did no trigger any malfunction and the pcb passed it.The cmagup was used to analyze the pcb when the m4 error was active.The voltages were measured in the h bridges and the 2nd bridge had a different behavior than the others.It was determined that the levitation fault was most likely caused by a h bridge component fail, triggered by high temperatures.To test this, the console was tested with a test motor and loop until the m4 alarm occurred.Once the alarm occurred, the motor couldn¿t start running at the set speed of 600 rpm.A freezer spray was applied over the 2nd h bridge and the error cleared, and the pump started running again.The old lmcebox pcb was replaced with a new one.The console was tested with a test motor and loop.The system was run at 5500 rpm with a flow of 9 lpm for one minute and then at 500 rpm with a flow of 1 lpm for one minute.The console was switched off and then on.This sequence was repeated 10 times and the console always functioned as intended.The console was reprocessed to the repair and maintenance procedure and passed all tests, including the final test and the electrical safety test.The console was forwarded to the edc (b)(4).The root cause for the m4 alarm was conclusively determined to be due to defective component in the h bridge.No further information was provided.The manufacturer is closing the file on this event.

Event Description

It was reported that the centrimag console alarmed "motor over temp" and the motor was hot to the touch while in use.The account changed to the back up centrimag device, no harm to the patient occurred as a result of the event.Product investigation later revealed the root cause of the m-4 alarm to be attributed to a defective component in the h bridge of the primary console.The root cause of the defective component in the h bridge was undetermined.No further information was provided.

• Brand Name: CENTRIMAG 2ND GENERATION PRIMARY CONSOLE WITH EM-TEC ADULT FLOW PROBE, OUS
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CA CH-80 05; SZ CH-8005
• MDR Report Key: 9161536
• MDR Text Key: 163003622
• Report Number: 2916596-2019-04756
• 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: foreign,other
• Type of Report: Initial,Followup
• Report Date: 02/23/2020

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: 201-90401
• Device Catalogue Number: 201-90401
• Device Lot Number: 6418796
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/18/2019
• Initial Date FDA Received: 10/07/2019
• Supplement Dates Manufacturer Received: 09/18/2019
• Supplement Dates FDA Received: 02/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1