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

Model Number L201-90411

Device Problems Electrical /Electronic Property Problem (1198); Infusion or Flow Problem (2964)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/04/2021

Event Type  malfunction  

Manufacturer Narrative

The event was reported as having no patient involvement.No further information was provided.A supplemental report will be submitted when the manufacturer's investigation is complete.

Event Description

Related mfr #s: 3003306248-2021-01077, 3003306248-2021-01078.It was reported that the centrimag console displayed error messages b4 and f3.Flow could not be increased with an increase in the rpm.The customer switched out the console, motor, and flow probe for their backups.

Manufacturer Narrative

Section d4 - expiration date: the expiration date field was incorrectly filled in the previous report.There is no expiration date associated with this device.Manufacturer's investigation conclusion: the reported event of a f3 alarm and the flow not increasing when the motor speed was increased was confirmed via analysis of the log file downloaded from the returned centrimag console and evaluation of the returned console.The reported event of a b4 alarm was not confirmed.On the reported event date of (b)(6) 2021, the system was observed to be operating at the set speed of approximately 3150 rpm/2.6 lpm.Intermittent f3: flow below minimum alarms were captured on (b)(6) 2021 at 01:50, 04:49, 11:55, and 16:56.The alarms were active due to the flow reading dropping below the flow minimum threshold.On the same date from 04:21 to 04:22, the flow reading was observed to be fluctuating, causing the flow reading to intermittently drop to 0 lpm.This resulted in f2: flow signal interrupted and f3: flow below minimum alarms activating.The alarms were cleared within a minute of activating.The motor speed was unaffected by the fluctuating flow values.The motor speed was changed several times on (b)(6) 2021 from 16:23 to 16:24 and from 19:51 to 19:54, ranging between 2400 rpm and 4450 rpm.The flow reading was observed to adjust appropriately to the changes to the motor set speed.The system was observed to be taken out of patient use on(b)(6) 2021 at 20:58 and was observed to not be in patient use for the remainder of the log file.No b4 alarms were observed throughout the log file.No other notable alarms were observed.The returned centrimag console (serial number: (b)(6)) was evaluated at the service depot alongside known working centrimag equipment.When the console was connected to a mock loop, flow alarms activated and the flow reading was observed to fluctuate, reproducing the reported event of flow alarms.The flow printed circuit board (pcb) was replaced and the issue resolved, isolating the issue to the flow pcb.The console¿s internal battery operated as intended; however, the battery was also replaced with a new component.After replacing the flow pcb and internal battery, the returned centrimag console was then functionally tested and fully functioned as intended during testing.The serviced and repaired unit was returned to the rental pool after passing all tests per procedure.The flow pcb was further evaluated by the product performance engineering (ppe) department.The flow pcb was tested alongside known working test centrimag equipment; however, the reported event was unable to be reproduced throughout ppe evaluation.Circuit analysis of the flow pcb did not reveal any issues that would have resulted in the reported event; therefore, the reported issue of the flow not increasing and an f3 alarm could not be isolated to a specific component.Although the root cause of the reported event of a f3 alarm and the flow not increasing when the motor speed was increased was narrowed down to an issue with the console¿s flow pcb, the root cause of the reported event could not be conclusively determined through this analysis.The root cause of the b4 alarm could not be conclusively determined through this analysis.The device history records were reviewed and the records revealed that the centrimag console, serial number (b)(6), was manufactured in accordance with manufacturing and quality assurance specifications.The 2nd generation centrimag system operating manual section 10 ¿ ¿emergencies/troubleshooting¿ provides instructions for operation when there is a need to exchange the main console or motor with a backup console or motor.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" cover all alarms (auditory and visual), including battery and flow related alarms, and the appropriate actions to take if the issue does not resolve.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG 2ND GENERATION PRIMARY CONSOLE RENT
• 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: 11598901
• MDR Text Key: 253826395
• Report Number: 3003306248-2021-01076
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 07640135140702
• UDI-Public: 07640135140702
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Model Number: L201-90411
• Device Catalogue Number: 201-90411
• Device Lot Number: IFS101753
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CENTRIMAG 1ST GENERATION ADULT FLOW PROBE ¿ 3/8¿; CENTRIMAG MOTOR