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

Model Number 201-90411

Device Problem Electrical Power Problem (2925)

Patient Problems Bradycardia (1751); Low Blood Pressure/ Hypotension (1914)

Event Date 05/04/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Related mfr for the motor in use: 3003306248-2022-10684.It was reported that the patient was being prepared for transport to computerized tomography (ct) scan while on extracorporeal membrane oxygenation (ecmo) with centrimag pump to console and motor.The console was moved to the bed without incident.The flows were stable and the patient was hemodynamically stable.After approximately 3 minutes the console alarmed for motor disconnected no flow alarm, and rotations per minute (rpm) was zero.The motor cable remained tightly connected and healthcare providers attempted to increase the rpms without success.The back-up console started and pump head was moved to a new motor.Rpms increased to 4700 and flows were 5.5 l which lasted less than 1 minute.During the stoppage the patient experienced a bradyasystolic arrest with heart rate in the 30s and blood pressure 20/20.The patient was given 0.5 mg epinephrine intravenous therapy push and the physician assistant performed chest compressions to circulate the drug.As soon as rpms and flow resumed the patient stabilized.Family withdrew support several days after the event due to no recovery of neurological status.

Manufacturer Narrative

Manufacturer's investigation conclusion: the centrimag 2nd generation primary console (serial #: (b)(6)) was returned for evaluation with the reported event of the console alarming for motor disconnect and no flow alarms and the motor speed dropping to 0 rpm.A review of the downloaded log file showed events spanning approximately 4 days (03may2022 ¿ 05may2022, 26may2022 per time stamp).Events occurring on 26may2022 took place during lab testing at abbott.The console was operating a motor at a speed of ~4600 rpm with a flow of ~5.1 lpm.On 04may1011 at 07:54 the system shutdown was initiated.A ¿motor disconnected: m2¿ alarm was active, and the speed dropped to 0 rpm and the flow was retrograde.A ¿system alert: s3¿ alarm activated.¿flow signal interrupted: f2¿ and ¿flow below minimum: f3¿ alarms were also present at these times.These alarms were able to be muted and cleared but continued to activate until the system was shutdown at 08:01.There were no other notable events active in the log file.The centrimag 2nd generation primary console was returned for analysis to the service depot.The console and returned and associated motor, and flow probe were connected to a test loop and run.During operation the motor cable was manipulated and caused the console to alarms and the pump to stop.The console and flow probe were then tested with a test motor on a test loop and operated as intended with no alarms for several days.A full functional test was performed, and all tests were passed.The reported event could not be correlated to an issue with the returned console.The device history records were reviewed for the centrimag 2nd generation primary console (serial #: (b)(6)) and the console was found to pass all manufacturing and qa specifications.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." the 2nd generation centrimag system operating manual section 10 entitled "emergency and troubleshooting" states that "the recommended practice whenever there is a 2nd generation centrimag primary 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 backup motor and console to continue patient support.Do not exchange individual motors or individual consoles during patient support." the 2nd generation centrimag system operating manual section 12.1 ¿appendix i ¿ console alarms and alerts¿ table 16 details how to properly interpret and troubleshoot all system alarms including m2, s3, f2, and f3 alarms.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: 14499560
• MDR Text Key: 294781643
• Report Number: 3003306248-2022-10683
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 07/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 201-90411
• Device Catalogue Number: 201-90411
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/05/2022
• Initial Date FDA Received: 05/25/2022
• Supplement Dates Manufacturer Received: 07/12/2022
• Supplement Dates FDA Received: 07/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/23/2015
• 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 Outcome(s): Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 83 KG