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

Model Number 201-90411

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem Asystole (4442)

Event Date 10/01/2020

Event Type  Injury  

Event Description

Medwatch report number: (b)(4).Related manufacturer report number: 3003306248-2021-00565.It was reported that the monitor alarmed showing b1 battery failure.The alarm was silenced by the perfusionist.It cleared and reset but the decision was made to switch the patient to the backup pump.The patient had 18 seconds of asystole with no blood pressure during the pump exchange.Epinephrine was not needed as the patient recovered after the new pump was returned to speed.

Manufacturer Narrative

No further information was provided.The manufacturer is closing the file on this event.

Event Description

Medwatch report number: (b)(4).

Manufacturer Narrative

Section b5: medwatch report number was corrected.Manufacturer's investigation conclusion: the reported event of a b1 alarm was not confirmed.The centrimag 2nd generation primary console was not returned for analysis.Multiple good faith efforts were sent to retrieve additional information regarding if any products would be returning for evaluation and what the serial number of the centrimag 2nd generation primary console is; however, no response was received.The root cause for the reported event was unable to be conclusively determined through this analysis.The 2nd generation centrimag system operating manual (rev.11) 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 (rev.11) 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 (rev.11) 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, including b1 alarms.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: 11497144
• MDR Text Key: 244608296
• Report Number: 3003306248-2021-01088
• 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,Followup
• Report Date: 05/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 201-90411
• Device Catalogue Number: 201-90411
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR