MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG 2ND GENERATION PRIMARY CONSOLE

Model Number 201-90411

Device Problem Visual Prompts will not Clear (2281)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/22/2019

Event Type  Injury  

Event Description

The patient was placed on extracorporeal circulatory support at an unspecified date.It was reported the blood pump was rattling, but still spinning.The console indicated for low flows and a system alert (s3) alarm.The system was switched to a new circuit (console, motor, and flow probe).Pump was working, but there were no flow readings and o rattling sound.The initial system was rebooted and the patient was switched back to initial system.Pump continued to rattle.The pump was then switched to the backup system again and worked properly.There was no adverse impact to the patient during this event.No further information was received.

Manufacturer Narrative

The primary system motor was reported on mfr.Report #2916596-2019-00676.The primary system flow probe was reported on mfr.Report #2916596-2019-00677.The backup system console was reported on mfr.Report #2916596-2019-00682.The backup system motor was reported on mfr.Report #2916596-2019-00683.The backup system flow probe was reported on mfr.Report #2916596-2019-00684.Approximate age of device - 10 months.Investigation conclusion: the reported event of low flow and a s3, system error alarms was confirmed through a log file analysis.The centrimag 2nd generation primary console (serial #: (b)(4)) was returned to the service depot for analysis.The returned centrimag 2nd generation primary console was evaluated and tested.The service depot was unable to confirm or duplicate the reported low flow and s3, system error alarms.The centrimag 2nd generation primary console was tested for an extended period with a test motor, test flow probe, and a test monitor as well as the associated motor (serial #: l05333-0005), flow probe (serial #: (b)(4)), and monitor (serial #: (b)(4)).As specified on the test, the console was run at all set rpm speeds.No flow issues and no s3 error messages occurred during testing.A successful routine battery maintenance was performed to the console¿s battery.Per field action ¿fa-q318-mcs-1¿, it was verified that the new backup system warning label was present on the back of the console.A full functional checkout was performed, and the unit passed all tests.A log file was extracted from the system for analysis.A review of the log file showed data spanning approximately 329 days (08mar18 ¿ 31jan19 per time stamp).At the timestamps of 03oct18 at 03:52, 20oct18 at 01:23, and (b)(6) 2019 at 14:10, ¿system alert: s3¿ were triggered and the flow dropped to 0 lpm and was coincident with the sub fault ¿sf_flow_low_amplitude¿ and the fault ¿flow signal interrupted: f2¿.The root cause for the low flow and a s3, system error alarms was not conclusively determined through this analysis.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." 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 has an emergency/troubleshooting section for the 2nd generation console.The recommended practice whenever there is a 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 back-up motor and console.Switch all components (console, motor, flow probe and cables) simultaneously to continue patient support, and then perform troubleshooting on the non-functioning system, when it is no longer being used for patient support.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.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG 2ND GENERATION PRIMARY CONSOLE
• Type of Device: PRIMARY CONSOLE
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• MDR Report Key: 8334183
• MDR Text Key: 136618522
• Report Number: 2916596-2019-00675
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 07640135140702
• UDI-Public: 07640135140702
• Combination Product (y/n): N
• 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: 04/25/2019

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: 201-90411
• Device Catalogue Number: 201-90411
• Device Lot Number: 6382423
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/22/2019
• Initial Date FDA Received: 02/12/2019
• Supplement Dates Manufacturer Received: 04/22/2019
• Supplement Dates FDA Received: 04/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 23 YR
• Patient Weight: 100