MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG MOTOR; MOTOR, RENTAL

Model Number L102956

Device Problems No Display/Image (1183); Decreased Pump Speed (1500)

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

Event Date 08/08/2019

Event Type  Injury  

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted when the manufacturer's investigation is completed.

Event Description

The patient was supported by an extracorporeal circulatory support device starting on (b)(6) 2019.It was reported that the an ¿s3 system alert¿ was observed.The rpm¿s went from 4500 to 3500 and flow through the sensor was not reading on the console screen.After consulting the troubleshooting guide, i tried acknowledging the alarm, but there was no resolution.Per the guide, we moved to the backup console, centrifugal motor and flow probe.The situation resolved immediately.There was no adverse event as a result of s3 system alert.No additional information was provided.

Manufacturer Narrative

The console in use during this event is reported under mfr # 2916596-2019-04047.Section d3: correction.Manufacturer's investigation conclusion: the reported events of the centrimag system experiencing an rpm drop with no displayed flow value was confirmed.A data log file was successfully retrieved from a 2nd gen.Primary console associated with this event (serial number (b)(4) and was reviewed.On (b)(6) 2019, the console was supporting the system at a speed of ~4500 rpm and a flow of ~4.02 lpm.On (b)(6) 2019 at 21:11, the log file captured an active system alert: s3 as a result of an active sf_ifd_shutdown_detected fault.After this event, speed dropped to ~3360 rpm and flow reading would have been blank with on the console display, consistent with the reported information.A set pump speed not reached: m5 alarm was captured within the same minute.The console was restarted multiple times, however it was not in use by a patient throughout the remainder of the log file starting after 21:23 of the same day, as the equipment was exchanged immediately.The patient did not experience adverse effects throughout the alarms or the exchange.The log file did not contain data on (b)(6) 2019 at 1:15.The console was not in use by the patient throughout the data on (b)(6) 2019, which began at 7:33.The returned centrimag motor was functionally tested by the ppe department, and under a work order on (b)(6) 2019.The reported events were unable to be reproduced and the motor appeared to function as intended throughout all testing.However, these events are consistent with the ifd_shutdown fault sequence observed within the log file.Reports of similar events have been documented and corrective action (capa) has been initiated to investigate the issue.The investigation has determined that the reported event of an rpm drop with no displayed flow, also correlating with s3 and m5 alarms, was caused by a motor related issue.Final disposition of the motors will be determined by the capa.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
• Type of Device: MOTOR, RENTAL
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CA CH-80 05; SZ CH-8005
• MDR Report Key: 8905991
• MDR Text Key: 154732420
• Report Number: 2916596-2019-03942
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 07640135140078
• UDI-Public: 07640135140078
• 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
• Report Date: 11/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: L102956
• Device Catalogue Number: L102956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/08/2019
• Initial Date FDA Received: 08/19/2019
• Supplement Dates Manufacturer Received: 11/05/2019
• Supplement Dates FDA Received: 11/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: FA-Q319-MCS-1
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 34 YR
• Patient Weight: 122