MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG MOTOR, US; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Model Number L102956

Device Problems Disconnection (1171); Insufficient Information (3190); Unexpected Shutdown (4019)

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: 3003306248-2022-12514.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported events of an accidental motor disconnection and an s3 alarm were confirmed via the log file that was extracted from the returned centrimag console during testing (serial number: (b)(6), evaluated separately).The system was observed to be operating at ~4200 rpm / 4.3 lpm on the reported event date of 03sep2022.An m2: motor disconnected alarm was observed on (b)(6) 2022 at 20:07 while the system was in use, temporarily stopping the system; this observation is consistent with the reported accidental motor disconnection.An s3: system alert alarm was also observed within this minute while the system was in use, correlating to a ¿can bus send error¿ sub-fault.The motor was reconnected within the minute, and the patient¿s rpm ramped back up to 4200 rpm at 20:08.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 motor (serial number: (b)(6) was functionally tested at the service depot and by the ppe department.The motor was tested alongside all returned equipment and alongside known working test equipment.The motor operated as intended throughout all testing, even when the motor¿s cable was manipulated by hand.The motor was scrapped due to an incidental finding of an irreparable kink on its cable; however, the kink did not affect the motor¿s functionality.The root cause of the accidental motor disconnection was reported to have been user error.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 and m2 alarms, as well as appropriate operator response to these events.The pump will stop in the event of an m2 alarm.Centrimag motor ifu, rev.06, instructs the user to inspect the centrimag motor, cable, console connector, and locking mechanism for any damage prior to use.If any component is damaged, do not use the centrimag motor.This document states that if the unit fails to operate according to the motor specifications or a console diagnostic error indicates a centrimag motor malfunction, it should be returned.Additionally, this document instructs the user to always have a spare centrimag motor and back-up equipment available.Review of the device history record for the centrimag motor, 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 MOTOR, US
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• 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: 15497573
• MDR Text Key: 306409251
• Report Number: 3003306248-2022-12515
• Device Sequence Number: 1
• Product Code: KFM
• UDI-Device Identifier: 07640135140078
• UDI-Public: 7640135140078
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020271
• 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 Model Number: L102956
• 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; 10/28/2022
• Supplement Dates FDA Received: 10/14/2022; 10/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/22/2018
• 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: 46 YR
• Patient Sex: Male
• Patient Weight: 68 KG