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

Model Number L102954

Device Problem Electrical /Electronic Property Problem (1198)

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

Event Date 07/04/2023

Event Type  malfunction  

Event Description

It was reported that the centrimag console had a battery failure.

Manufacturer Narrative

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

Manufacturer Narrative

Manufacturer report number for centrimag console should be fei-based mfr # 3003306248-2023-05027, not cfn number.Manufacturer's investigation conclusion: incidental findings: atypical s1 alarm active during testing at the edc and damaged housing of the console the reported event of a b1 alarm active on the centrimag console was confirmed.The centrimag console (serial number (b)(6) was returned and evaluated at the european distribution center (edc) and a log file was downloaded.The log file downloaded at the edc and the log file downloaded during product performance engineering (ppe) testing contained overlapping data captured on several different days spanning (b)(6) 2023 - per the timestamp).Data captured after (b)(6) 2023 is consistent with data captured while the console was returned to the european distribution center and product performance engineering.Throughout the log file, the console was operating a motor at a speed of between 0 rpm and approximately 3700 rpm.The log file captured an atypical b1 alarm active on (b)(6) 2023 at 9:46:28, 9:48:10, 15:53:21, 17:03:42, and 18:33:57 due to a sf_sps_battery_selftest sub fault flag.The alarm was muted each time it was active and did not clear on its own.Pump speed remained at 0 rpm while the b1 alarm were active.During the evaluation, the console was connected to a mock circulatory loop for an extended period of time and a b1 alarm was active, confirming the reported event.The unit was then forwarded to ppe for further analysis.During ppe analysis the unit was placed on a mock circulatory loop and the b1 was active.The sps (charger printed circuit board (pcb)) underwent circuit analysis.A diode (component d502) was observed to be electrically open and irregular voltages were measured on the smb_c line compared to a reference diode, indicating that the diode was not operating as intended.No further troubleshooting was completed at this time as the component was unable to be replaced without damaging the pcb.The root cause of the reported event was determined to be an electrically compromised component on the charger pcb.Review of the device history record for the centrimag 2nd generation primary console , serial number (b)(6) , showed the device was manufactured in accordance with manufacturing and qa specifications.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 4 entitled "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." 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 CA CH-80 05; SZ CH-8005
• Manufacturer (Section G): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CA CH-80 05; SZ CH-8005
• Manufacturer Contact: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 17375263
• MDR Text Key: 319682284
• Report Number: 3003306248-2023-05027
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 07640135140702
• UDI-Public: 7640135140702
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K020271
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: L102954
• Device Lot Number: 7369723
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/06/2014
• 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