MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG MOTOR; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Model Number L102956

Device Problems Vibration (1674); Noise, Audible (3273)

Patient Problem No Patient Involvement (2645)

Event Date 04/08/2019

Event Type  malfunction  

Manufacturer Narrative

There was no patient involved, therefore no patient info.Approximate age of device ¿ 8 years 9 months (age of device was calculated from manufacture date to event date).Manufacturer's investigation conclusion: the reported event of the centrimag motor producing a loud noise when in use was confirmed.The returned centrimag motor (serial number (b)(4)) was tested under a work order on (b)(6) 2019.The motor was connected to the returned centrimag console (serial number (b)(4)) and flow probe (serial number (b)(4)).The motor produced an abnormally loud sound when the cable near the motor end was moved or slightly bent.The centrimag motor was also tested.It was determined that the motor had a defective cable after performing a resistance and insulation test on the cable.The cable failed at b2+ and b2-; when manipulating the motor cord end, the resistance reading would become an open loop.The motor failed the insulation test at all points while one probe was connected to the emc.The centrimag motor was returned for destructive testing.The centrimag motor was connected to a test centrimag 2nd gen.Primary console.The reported event of loud noises occurring when the cable was bent was confirmed.At low pump speeds (under 2000 rpm), the pump intermittently stopped when the motor¿s cable was manipulated near its base.Manipulation did not cause the pump to stop at higher speeds, but loud noises were heard.A motor alarm (m4) was active when the motor was initially connected.A log file was extracted from the returned centrimag console and was reviewed.The log file contained data spanning 32 days within the timeframe of the reported event ((b)(6) 2019 ¿(b)(6) 2019 per time stamp, and (b)(6) 2019 per time stamp).Motor alarms (m4) were active on (b)(6) 2019 at 10:00 and 10:34, and on (b)(6) 2019 at 4:13.The alarms cleared when the system was shut down and restarted, however this was not a permanent solution to the issue.No other notable events occurred throughout the log file.The motor¿s cable was stripped in order to examine the wires.Significant damage to the brown, pink, and gray cables were observed.These wires are responsible for the output current of bearing phase b2, the output current of drive phase b1, and the input current of drive phase b1 respectively.The brown cable was able to be snapped open, revealing that the wire within the cable had completely deteriorated.The tear on the pink wire revealed its shielding, confirming the possibility of a short-to-shield within that wire.The remainder of the wires were frayed and dirty.The root cause of the reported event was conductor breakdown found within the motor¿s cable.No further information was provided.The manufacturer is closing the file on this event.

Event Description

It was reported that during a wet lab if the motor was moved, a extremely loud noise would be made and the motor would vibrate aggressively.If the motor cord was moved, it would do the same.No alarms ever came on.

• Brand Name: CENTRIMAG MOTOR
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• MDR Report Key: 8850871
• MDR Text Key: 182986132
• Report Number: 2916596-2019-03555
• Device Sequence Number: 1
• Product Code: KFM
• 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: company representative,health
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 06/09/2021

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
• Device Catalogue Number: L102956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/30/2019
• Initial Date FDA Received: 08/01/2019
• Supplement Dates Manufacturer Received: 02/10/2020; 06/09/2021
• Supplement Dates FDA Received: 02/24/2020; 06/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: FA-Q318-MCS-1
• Patient Sequence Number: 1