MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG MOTOR, US; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Model Number 102956

Device Problems Display or Visual Feedback Problem (1184); Infusion or Flow Problem (2964)

Patient Problem No Patient Involvement (2645)

Event Date 06/20/2020

Event Type  malfunction  

Manufacturer Narrative

No patient information - no patient involvement.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

Related manufacturer's reference number: 3003306248-2020-00060.It was reported that during analysis of the log file that was extracted from the returned centrimag console (sn: (b)(4)) on 02sep2020, an s3 alarm caused by an ifd shutdown event was observed to have occurred on (b)(6) 2020.A drop in repetitions per minute and blanking of the flow values was associated with this event, and this issue is associated with a field safety corrective action (fsca).The hospital's perfusionists were unable to identify which centrimag motor was being used at the time of this event; therefore the device will not be returned for evaluation.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of an s3 alarm caused by an ifd_shutdown sub-fault, correlating to a drop in rpm and a blank flow reading, was confirmed via a log file extracted from the centrimag console during testing.Per the log file, on 20jun2020, the system was operating at a set speed of approximately 4200 rpm / 3.8 lpm.On 20jun2020 at 15:01, an s3 alarm became active as a result of an active sf_ifd_shutdown_detected fault.After this event, speed dropped to approximately 3350 rpm and the flow reading was blank, reading as 0.0 lpm.The motor was flagged as being disconnected at 15:05, and reconnected at 15:07.The rpm was able to be reset back to standard values; however, the flow reading remained blank due to the s3 alarm.The console was shut down at 15:43 and was not observed to be in patient use throughout the remainder of the log file.The centrimag motor (serial number unknown) used at the time of this event was unable to be determined.Reports of similar events have been documented and corrective action has been initiated to investigate the issue.An issue with the motor was determined to be the root cause of the reported event.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 / 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: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• MDR Report Key: 10540441
• MDR Text Key: 207145251
• Report Number: 3003306248-2020-00078
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• PMA/PMN Number: K020271
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 12/04/2020

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: 102956
• Device Catalogue Number: 102956
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/02/2020
• Initial Date FDA Received: 09/16/2020
• Supplement Dates Manufacturer Received: 12/01/2020
• Supplement Dates FDA Received: 12/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: FA-Q319-MCS-1
• Patient Sequence Number: 1
• Treatment: CENTRIMAG PRIMARY CONSOLE (SN: (B)(4)); CENTRIMAG PRIMARY CONSOLE (SN: (B)(4))