MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG MOTOR, US

Model Number 102956

Device Problems Decreased Pump Speed (1500); Insufficient Flow or Under Infusion (2182); Noise, Audible (3273)

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

Event Date 06/07/2019

Event Type  Injury  

Manufacturer Narrative

Multiple attempts were made to obtain patient information however none was provided.Console reported under: mfr# 2916596-2019-02778.Serial number of the devices was requested but not provided.No further information was provided.A supplemental report will be submitted when the manufacture's investigation is completed.

Event Description

It was reported that the patient gen 2 primary console was running at 4000 rpm and alarmed and then dropped to 3300rpm.Unable to get the rpm to go back up and therefore the primary console was exchanged.It was reported a humming noise was heard from the motor.Centrimag gen 2 monitor showed decreasing flow unresponsive to clinician¿s attempt to increase flow.Flow continued to decrease resulting in patient composition.Patient clamped off ecmo and converted to back up motor.Flow resumed without further issue.

Manufacturer Narrative

The device was not returned for evaluation.The complaint investigation determined the reported difficulty was the result of a design related issue.After review of this event and similar incidents, abbott has decided to initiate a voluntary field action for centrimag.Abbott performed a comprehensive investigation which included device analysis, manufacturing evaluation and trend analysis.

Manufacturer Narrative

Manufacturer's investigation conclusion: the report of a centrimag 2nd gen primary console alarming, a speed drop to ~3300rpm, and a decreased flow reading was confirmed through the analysis of a data log file retrieved from the returned centrimag 2nd gen primary console (evaluated under mfr# 2916596-2019-02778) associated with this event.Per the log file, on (b)(6) 2019 the console was supporting a system at a speed of ~4000rpm and a flow of ~4.1lpm for over 103 hours without any issues.At approximately 10:59pm on (b)(6) 2019 the log file captured a system alert:s3 alarm as a result of an active sf_ifd_shutdown_detected fault.Following this event speed dropped to ~3300rpm and the flow reading became blank with a reading of 0lpm, consistent with reported information.Although the flow reading was 0, flow would have continued to be present.The console then alarmed with a pump speed not reached:m5 alarm and ~1 minute later with a flow signal interrupted:f2 alarm.Attempts to adjust pump speed were unsuccessful.At ~11:09pm the motor was disconnected and the console was powered down at ~11:10pm.The centrimag motor used at the time of the reported event was not returned for analysis.Multiple attempts to obtain the product were unsuccessful.As a result, the functionality of the motor could not be evaluated.However, reports of similar events have been documented and corrective action (capa) was initiated to investigate the issue.This investigation determined that these types of events are related to the motor used at the time.Corrective action has been implemented to address the issue.Reports of similar events will continue to be tracked and monitored.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, 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 MOTOR, US
• Type of Device: CENTRIMAG MOTOR
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• MDR Report Key: 8745895
• MDR Text Key: 149561154
• Report Number: 2916596-2019-03112
• 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: health professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 102956
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: FA-Q319-MCS-1
• Patient Sequence Number: 1