MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH PRIM CONS 1ST GEN, STANDALONE; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 201-90150

Device Problems Display or Visual Feedback Problem (1184); Insufficient Information (3190)

Patient Problem Low Oxygen Saturation (2477)

Event Date 04/08/2020

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 before venous-venous (vv) ecmo retrieval, the cmag console was tested.When the patient was on vv ecmo and before departure back to the hospital, an s3 system alert occurred.The motor was functioning but no flow reading was being displayed.The flow probe from the spare console was utilized.When transporting the patient the alarm remained and consistently alarmed.A motor and console change was done.The patient's saturation dropped but recovered fully.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of an s3 alarm was confirmed.A log file was extracted from the returned centrimag console and was reviewed.The system operated at speeds around the set speed throughout all data observed on the event date, 08apr2020.A can bus send error sub-fault was observed on 08apr2020 at 12:19, causing the reported s3 alarm.Flow readings were observed to be 0 lpm after the observed s3 alarm due to the can bus send error sub-fault.The system was manually shut down at 12:20.No other notable events were observed.The returned centrimag console (serial number (b)(6) ) was functionally tested at the european distribution center on 12may2020.The console was functionally tested and was found to perform as intended ¿ no atypical events occurred throughout all testing.S3 alarms caused by a can bus error sub-fault were stated to resolve upon power cycling the console.The console was returned to the customer site after passing all tests per procedure.The root cause of the reported event was unable to be conclusively determined through this analysis.Reports of similar events will continue to be tracked and monitored.Review of the device history record for centrimag console s/n l00934-0007 showed the device was manufactured in accordance with manufacturing and qa specifications.The 2nd generation centrimag system operating manual section 4-"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-"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.The 2nd generation centrimag system operating manual section 12.1-"appendix i - primary console alarms and alerts" contains a list of console alarms and alerts, including s3 alarms, 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: PRIM CONS 1ST GEN, STANDALONE
• 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: 10020123
• MDR Text Key: 189745273
• Report Number: 3003306248-2020-00030
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 07/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 201-90150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention