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

Model Number 201-90411

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/16/2019

Event Type  Injury  

Manufacturer Narrative

This event was also reported against the centrimag motor under mfr.Report #2916596-2020-00002.Patient info was requested but not provided.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 was on bi-vad centrimag (cmag) support with complaint of no flow showing on the right ventricular assist device (rvad) side.Patient was asymptomatic and flow appeared normal as patient was stable.Attempted new flow probe on the right side to no avail.Used the flow probe from the left side to ensure the flow probe worked and it did.That same flow probe was then attached to the rvad console and did not record a flow.The team then decided to switch out the rvad console with the backup console and flow again was recording.When the original rvad was attached to the mock loop, flow was normal.No further information was provided.

Event Description

Additional information was provided that the issue resolved on the same day the customer called in the concern.No further information was provided.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of the no flow being displayed was not confirmed.The centrimag 2nd generation primary console (serial #: (b)(6) ) was not returned for analysis.The root cause for the reported event 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." 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 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 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: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• MDR Report Key: 9582048
• MDR Text Key: 175023512
• Report Number: 2916596-2019-06108
• 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: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2020
• 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: 04/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention