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

Model Number 201-90411

Device Problems Improper or Incorrect Procedure or Method (2017); Infusion or Flow Problem (2964); Insufficient Information (3190)

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

Event Date 09/03/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the healthcare provider inadvertently disconnected the driveline from the console instead of the monitor cable while packing up the patient to transport to the computed tomography (ct) scanner.The error was immediately noted and the nurse reinserted the driveline cable into the console after which the pump resumed to its previous speed.The patient tolerated the event without issue.An s3 error code was activated at the time and the nurse attempted to clear the alarm.However, although the alarm banner cleared and the pump speed was displayed, the pump flow banner showed only arrows.This occurred on the monitor and the console.The nurse attempted to recreate the event once the patient was no longer on the centrimag console; it took three attempts for the message to repeat itself.

Manufacturer Narrative

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

Event Description

Related manufacturer report number: 3003306248-2022-12515.

Manufacturer Narrative

Section d4: expiration date inadvertently reported in initial report and is not applicable for this device.Manufacturer's investigation conclusion: the reported event of an s3 alarm was confirmed via the log file that was extracted from the returned centrimag console during testing (serial number: (b)(6).The system was observed to be operating at ~4200 rpm / 4.3 lpm on the reported event date of 03sep2022.An s3: system alert alarm was observed on (b)(6) 2022 at 20:07 while the system was in use, correlating to a ¿can bus send error¿ sub-fault.The patient¿s displayed flow value became 0 lpm due to the can bus send error sub-fault.The system was observed to have been manually shut down at 20:18.S3 alarms correlating to can bus send error sub-faults were also observed on (b)(6) 2022 at 21:02 and on (b)(6) 2022 at 14:04.These alarms appeared to have been during timeframes where the system was not in patient use.No other notable events were observed.The returned centrimag console was received at the service depot and was tested alongside the returned flow probe (serial number 110829) and the returned centrimag motor (serial number: (b)(6) for an extended period; however, atypical events were unable to be reproduced.The console was functionally tested and was returned to the customer site after passing all tests per procedure.The root cause of the reported event was unable to be conclusively determined through this analysis.The 2nd generation centrimag system operating manual, rev.M, section 4 ¿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, rev.M, ¿table 15: console maintenance schedule¿ instructs users to have the centrimag console¿s internal battery replaced every two years.Users are instructed to contact abbott for assistance in replacing the battery, as users may not replace the internal battery without proper training or assistance.The 2nd generation centrimag system operating manual, rev.M, section 12.1-"appendix i - primary console alarms and alerts" contains a list of console alarms and alerts, including s3 alarms, as well as appropriate operator response to these events.Review of the device history record for the centrimag 2nd gen.Primary console, serial number: (b)(6), showed the device was manufactured in accordance with manufacturing and qa specifications.No further information was provided.The manufacturer is closing the file on this event.

• 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: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 15497491
• MDR Text Key: 306285850
• Report Number: 3003306248-2022-12514
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 07640135140702
• UDI-Public: 7640135140702
• 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,Followup
• Report Date: 10/31/2022

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 Expiration Date: 07/31/2022
• Device Model Number: 201-90411
• Device Lot Number: 7571523
• 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: 09/07/2022
• Initial Date FDA Received: 09/28/2022
• Supplement Dates Manufacturer Received: 09/22/2022; 10/20/2022
• Supplement Dates FDA Received: 10/14/2022; 10/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/25/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Sex: Male
• Patient Weight: 68 KG