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

Model Number 201-90411

Device Problem Decreased Pump Speed (1500)

Patient Problem Hemolysis (1886)

Event Date 06/14/2021

Event Type  Injury  

Manufacturer Narrative

The patient's gender was not provided.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 patient was initiated with centrimag veno-venous (vv) extracorporeal membrane oxygenation (ecmo) on (b)(6) 2021.It was set to 5450 rpm/7.03 lpm.The system never reached 5500 rpm and would not reach 5450 by 19:00 on (b)(6) 2021.At 5400 rpm and 6.95 lpm flow the patient had a circuit change for hemolysis on (b)(6) 2021.The patient was still on the current centrimag and never achieved 5500 rpms.The console and motor were placed on (b)(6) primed circuit and tested to see if 5500 rpms could be achieved.The circuit ran at 5500 rpms for greater than 2 hours.The circuit was placed on a demo training loop at approximately 14:00 and the rpms were at 5500 with flow at approximately at 6.74 lpms.When clamped/unclamped on the drainage side, rpms would fluctuate above/below 50-100 rpms but quickly returned to the 5500 rpm setting.It was unable to reproduce the sustained lower rpm reported issue.The circuit would continue to run on a training loop with added resistance to attempt to simulate the previous patient's settings for greater than 24 hours.It was felt that 5500 rpms were unable to be achieved related to the patient factors.Plan was to perform demo loop run and follow up with staff.Related manufacturer report number of motor: 3002893813-2021-00001.Related manufacturer report number of pump: 3002953813-2021-00004.

Manufacturer Narrative

Section d4: correction.Expiration date not applicable.Manufacturer's investigation conclusion: the reported event of not being able to reach 5500 rpm was not confirmed.The centrimag console (serial#: (b)(6) was returned for analysis and a log file was for review.A review of the downloaded log file showed events spanning approximately 4 days (on (b)(6) 2021 per time stamp).Events occurring on 10aug2021 took place during lab testing at abbott.Throughout the log file, the motor speed was adjusted several times.When the motor speed was adjusted to 5500 rpm, the motor was able to operate at a speed of, around, or slightly above 5500 rpm.There were no other notable alarms active in the log file.The centrimag motor was returned for and the reported event was unable to be confirmed via testing.The console was connected with the returned and associated equipment as well as to test equipment.The console was run for several days at 5500 rpm with no observed issues.The console was able to maintain a speed at 5500 rpm.The console was functionally tested and passed all tests.The root cause for the reported event was unable to be conclusively determined through this analysis.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 quality assurance 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 entitled "appendix i ¿ primary console alarms and alerts" contains a list of console alarms and alerts, 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
• MDR Report Key: 12283139
• MDR Text Key: 280523382
• Report Number: 3002953813-2021-00003
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• PMA/PMN Number: K131179
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2022
• Device Model Number: 201-90411
• Device Lot Number: 7530545
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 41 YR
• Patient Weight: 137