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

Model Number 201-30300

Device Problem Insufficient Information (3190)

Patient Problem Low Oxygen Saturation (2477)

Event Date 08/17/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Related manufacturer's report #s: 3003306248-2021-04033, 3003306248-2021-04032.It was reported that the patient was on centrimag support, when an s3 alarm displayed.The patient's physicians proceeded to change the flow probe.After the flow probe was exchanged, the flow value was no longer visible and the alarm persisted.The patient's spo2 levels dropped.The console and the motor were exchanged, and the system then continued working without any further alarms.

Manufacturer Narrative

Manufacturer's investigation conclusion: the device history records were reviewed for 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 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, including s3, m3, m2, f1, and f2 alarms.The reported event of a s3 alarm and no flow displayed was confirmed via the log file.The centrimag 2nd generation primary console (serial #: (b)(6) ) was returned for analysis and a log file was downloaded for review.A review of the downloaded log file showed events spanning approximately 4 days ((b)(6) 2021 per time stamp).Events occurring on (b)(6) 2021 took place during lab testing at abbott.On (b)(6) 2021 at 02:45:59 the console was powered on.The console alarmed for ¿pump not inserted: m3¿ and ¿flow sensor disconnected: f1¿ at 02:46:20 before the date and time of the system was synced.At 03:02:14, the support type was selected.A ¿motor disconnected: m2¿ alarm activated at 03:03:40 and was followed by a ¿system alert: s3¿ at 03:03:42.The f1, m2 and m3 alarms were able to be cleared; however, continued to intermittently activate.At 03:11:41 the motor speed was increased to 1500 rpm before being decreased to 0 rpm.The speed was changed several times, and always increased as intended; however, the flow remained at 0 lpm.¿flow signal interrupted: f2¿ alarms intermittently activated and cleared during this event.The console was powered down at 04:30:30.There were no other notable alarms active in the log file.The centrimag 2nd generation primary console was returned for analysis and the reported event was unable to be reproduced.The console was tested with the returned and associated centrimag motor, flow probe, monitor to console cable, and a mock loop for several days and there were no alarms observed.The console was run independent of the motor and functioned as intended.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.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: 12491646
• MDR Text Key: 274060421
• Report Number: 3003306248-2021-04044
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K131179
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/09/2021

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: 201-30300
• Device Lot Number: L06945
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/18/2021
• Initial Date FDA Received: 09/17/2021
• Supplement Dates Manufacturer Received: 11/10/2021
• Supplement Dates FDA Received: 12/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2020
• 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