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

Model Number 201-90411

Device Problem No Apparent Adverse Event (3189)

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

Event Date 01/12/2021

Event Type  malfunction  

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of the centrimag console damaging ac fuses was confirmed.The returned centrimag console (serial number (b)(4)) was received and tested at the service depot.When the console was powered on, it would operate on battery power and would cause fuses to be damaged.The consoles 24v power supply pcb was inspected and was observed to have no voltage output.The power supply was replaced with a new component, and the console was found to operate as intended after this replacement.A full functional checkout was performed, and the repaired console was returned to the customer site after passing all tests per procedure.A log file was also extracted from the console and was reviewed.Throughout events recorded on (b)(6) 2021, the console was not observed to be in patient use.The console was observed to have been powered on and off multiple times, and the console would alarm with b6: on battery within the same minute of powering on every time.These events were consistent with the testing of the returned console, as a damaged power supply pcb would cause the console to operate on battery power.The root cause of the reported event was damage to the consoles power supply pcb; however, the root cause of the damage to the power supply was unable to be conclusively determined.An s1: power on self test fail alarm was also observed on (b)(6) 2020 at 20:07 when the console was powered on.The console was observed to have been powered cycled within the same minute, and the alarm did not reoccur throughout the remainder of the data.The system was observed to have not been in patient use during this timeframe.No other notable events were observed.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, including s1 alarms, as well as appropriate operator response to these events.Review of the device history record for the centrimag console, serial number (b)(4) , showed the device was manufactured in accordance with manufacturing and qa specifications.No further information was provided.The manufacturer is closing the file on this event.

Event Description

It was reported that the centrimag main console was blowing ac fuses.

Manufacturer Narrative

Section d3 and g1 corrected.

• Brand Name: CENTRIMAG 2ND GENERATION PRIMARY CONSOLE
• 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: 11890359
• MDR Text Key: 253824491
• Report Number: 3003306248-2021-02967
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 07640135140702
• UDI-Public: 07640135140702
• 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,health
• Type of Report: Initial,Followup
• Report Date: 05/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 201-90411
• Device Catalogue Number: 201-90411
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1