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

Model Number 201-90411

Device Problems No Flow (2991); Insufficient Information (3190)

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

Event Date 01/12/2024

Event Type  malfunction  

Event Description

It was reported that the clinician was called up to the intensive care unit (icu) to help troubleshoot the centrimag because it was alarming with no flow.The icu team reportedly unplugged the motor in use and plugged it into the emergency backup console without a restoration in flow or resolution of the alarm.The team then decided to switch the pump over to the emergency back-up motor.Flow was restored with pump inserted in back-up motor and back-up console.Related manufacturer reference number: 3003306248-2024-00023.

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.

Manufacturer Narrative

Incidental finding: the console battery was observed to be expired.E1: reporter email was not available.Manufacturer¿s investigation conclusion: the reported event of the centrimag console alarming with no flow was confirmed via analysis of the submitted log file; however, the reported event could not be reproduced during testing.The centrimag console (serial number (b)(6)) was returned and evaluated at the service depot and a log file was downloaded.The submitted log file contained relevant events spanning approximately 4 days (11jan2024 ¿ 12jan2024, and 16jan2024, per the timestamp).The console was operating at approximately 3900 revolutions per minute (rpm) with a flow of approximately 4.5 liters per minute (lpm).On 12jan2023 at 17:08:47 an atypical shutdown of the console (sub fault sf_ifd_shutdown_detected) was observed; however, the console does not appear to be powered off.Other atypical system shutdowns were active at 12jan2024 at 17:10:37, 17:11:20, and 17:11:40 and the root cause is unknown.At 17:08:47, the speed dropped to 0 rpm and the flow dropped to 0 lpm.This triggered an f2 (sf_flow_low_amplitude) fault due to the flow dropping below the minimum threshold.Additionally, on 12jan2024 at 17:08:49, the log file captured an atypical m2 alarm active due to a sf_lmc_motor_disconnected sub fault.The alarm was muted and cleared at 7:10:08.The log file then captured an atypical f3 alarm active on 12jan2024 at 17:08:51 due to a sf_ifd_flow_below_min sub fault.The alarm was muted and then cleared on 17:10:08.The log file then captured an atypical m4 alarm on 12jan2024 at 17:09:14 due to a sf_lmc_levitation sub fault.The alarm muted and cleared at 17:10:39.An atypical s3 alarm was then captured at 12jan2024 at 17:09:20 due to a sf_lmc_local_iic sub fault.The alarm was muted and cleared at 17:10:40.All atypical alarms listed above were active intermittently until the last alarm cleared on 12jan2024 at 175:50.The system was then power cycled several times until it was returned to the service depot on 16feb2024.During the evaluation, the console, motor, and flow probe were connected to a mock circulatory loop for an extended period of time and no issues or atypical alarms were active.The returned console was opened and inspected and no physical anomalies were observed.The console was then functionally tested and passed all steps without issue.The root cause of the reported event could not be conclusively determined through this analysis.Review of the device history record for centrimag 2nd generation primary console showed the device was manufactured in accordance with manufacturing and qa specifications.The 2nd generation centrimag system operating manual section 3 "warnings and 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 11.1-"appendix i ¿ console alarms and alerts" contains a list of console alarms and alerts, including flow- and pressure-related alarms, as well as appropriate operator response to these events.No further information was provided.The manufacturer is closing the file on this event.

Event Description

It was reported that the alarm did not resolve on the original equipment; thus, it was sent for evaluation.The device was explanted as deemed appropriate by the medical team and patient plan of care.The patient was stable.

• 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
• Manufacturer (Section G): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• Manufacturer Contact: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 18565436
• MDR Text Key: 333506267
• Report Number: 3003306248-2024-00022
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 07640135140702
• UDI-Public: 07640135140702
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131179
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/26/2024

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: 201-90411
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/17/2024
• Initial Date FDA Received: 01/23/2024
• Supplement Dates Manufacturer Received: 04/23/2024
• Supplement Dates FDA Received: 04/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/07/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 57 KG