MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG 2ND GENERATION PRIMARY CONSOLE; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 201-30300

Device Problem Overheating of Device (1437)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/04/2021

Event Type  malfunction  

Manufacturer Narrative

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 patient's centrimag had a burning smell coming from it while supporting patient for centrimag rvad and console was switched on battery support despite being plugged in.The motor was observed to be heated.The console cable and motor were exchanged.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of a burning smell and the console operating on battery power was confirmed.The centrimag 2nd generation primary console (serial #: (b)(6)) was returned for analysis to the european distribution center (edc).The console was powered on and booted up as intended.However, after one minute, a burning smell was observed.After opening the system, sparks were observed on the 24v power supply.The console is a v1 and is no longer repairable.The console was forwarded to product performance engineering (ppe) for further analysis.The console was opened and burn damage was observed on the power supply printed circuit board (pcb).He console was powered on and the power supply was confirmed to be nonfunctional because despite being plugged into wall power, the console would only operate on battery power and an ¿on battery: b6¿ alarm was active.The console was able to operate a motor and a mock loop while operating on battery power.The observed damage to the power supply pcb was unable to be narrowed down to a specific component.The root cause for the console operating on battery power was conclusively determined to be due to a damaged power supply.However, the root cause for the damage to the power supply was unable to be conclusively determined through this analysis.There was also an incidental finding of a power on self-test fail: s1 alarm.The device history records were reviewed for the centrimag 2nd generation primary console (serial #: (b)(6)) and the console was found to be manufactured in accordance with manufacturing and qa specifications.The 2nd generation centrimag system operating manual section 4 entitled "warnings & precautions" warns "one additional 2nd generation centrimag primary console, motor and flow probe are required as backup system in the immediate vicinity of each patient whenever the centrimag or pedivas blood pump is used.The backup console must be connected to the backup motor and to the backup flow probe, have a battery charge sufficient for at least one hour of operation, be connected to ac power (except during transport) and be immediately available should the main console, motor or flow probe experience a malfunction." the 2nd generation centrimag system operating manual section 10 entitled "emergency and troubleshooting" 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.Do not exchange individual motors or individual consoles during patient support." the 2nd generation centrimag system operating manual section 12.1 entitled "appendix i ¿ primary console alarms and alerts" contains a list of console alarms and alerts, as well as appropriate operator response to these events.The 2nd generation centrimag system operating manual ¿table 1: distinction between version 1 & version 2¿ depicts that only version 2 consoles provide support to the monitor on battery mode.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG 2ND GENERATION PRIMARY CONSOLE
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• MDR Report Key: 11202713
• MDR Text Key: 258698453
• Report Number: 3003306248-2021-00005
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• PMA/PMN Number: K131179
• 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: 03/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2021
• 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
• Device Lot Number: 7816749
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CENTRIMAG MOTOR