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

Model Number 201-90401

Device Problem Failure of Device to Self-Test (2937)

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

Event Date 12/04/2022

Event Type  malfunction  

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.Initial reporter name and address: phone number: (b)(6).

Event Description

It was reported that the centrimag console had a power on self-test, s1 alarm, prior to being used on a patient.

Manufacturer Narrative

Manufacturer's investigation conclusion: incidental findings: s3 alarm due to sticking power button, damaged housing and missing maintenance history card, expired battery.The reported event of the centrimag console not passing its power on self-test was confirmed.A log file was extracted from the returned centrimag console (serial number (b)(6)).A few atypical s1: ¿power-on self-test¿ alarms were observed throughout the data recorded on (b)(6) 2022 and (b)(6) 2022 when the system was powered on, correlating to sub-faults that indicated a potential issue with the console¿s power button.The system was not observed to have been in patient use throughout the data.No other notable events were observed.The returned centrimag console was received at the european distribution center (edc).The console was functionally tested, and the power button was observed to stick upon being pressed.Although s1 alarms were not reproduced, an inconsistent power button could cause s1 alarms to intermittently occur during the power-on self test.The console¿s power button was replaced with a new component, then the serviced and repaired console was returned to the customer site after passing all tests per procedure.The centrimag console¿s original power button was forwarded to the product performance engineering (ppe) department for further analysis; however, no issues with the power button were observed throughout all ppe testing, and the power button functioned as intended while in use with known working test equipment.The root cause of the reported event was determined to be an issue with the console¿s power button; however, the root cause of the button¿s inconsistent issue was unable to be conclusively determined through this analysis.Review of the device history record for centrimag console, serial number (b)(6), showed the device was manufactured in accordance with manufacturing and qa specifications.The 2nd generation centrimag system operating manual (rev.L) 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 (rev.L, ¿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.L) section 11.1-"appendix i ¿ console alarms and alerts" contains a list of console alarms and alerts, including s1 and s3 alarms, 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 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: 15991639
• MDR Text Key: 308204131
• Report Number: 3003306248-2022-14528
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K093832
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 201-90401
• Device Catalogue Number: 201-90401
• Device Lot Number: 7351581
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2019
• 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