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

Model Number 201-90411

Device Problem Pumping Stopped (1503)

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

Event Date 08/29/2023

Event Type  malfunction  

Event Description

It was reported that the patient had a blood pump exchange with oxygenator removal on (b)(6) 2023.On an unidentified date the patient was on support and had a brief pump stop where the speed and flow both went to 0 simultaneously for a couple of seconds and then returned to baseline without intervention.Once it occurred twice on the patient, the motor, console, and flow probe were exchanged and sent for evaluation but came back good.The same thing happened again on (b)(6) 2023.The patient's speed and flow went to 0 for reportedly 6 seconds and then back to baseline.The nurse reported that the pump running sound disappeared as if it truly stopped during that time.No hemodynamic changes were noted.Flow went back up to baseline without intervention from the nursing staff.The customer reported that the only constant through multiple events was the patient's pump.The customer also noted that the pump was more "loose" than previous pumps.No adverse consequences were reported and the patient remained stable on the same pedimag.Related manufacturer reference number for the exchanged motor: 3003306248-2024-00027 related manufacturer reference number for the loose pump: 3003306248-2024-00001 related manufacturer reference number for the exchanged pump: 3003306248-2024-00021 related manufacturer reference number for the second motor: 3003306248-2024-00002 related manufacturer reference number for the second console: 2916596-2024-00137.

Manufacturer Narrative

Section d4: serial number was requested but has not been provided.No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.

Manufacturer Narrative

Manufacturer¿s investigation conclusion: the reported event of brief pump stops that caused the speed and flow to fall to 0 was unable to be confirmed.The centrimag 2nd generation primary console (s/n: unknown) was not returned for analysis.It was stated by the account that the reported issue was communicated awhile back; however, it is unknown the date of the pump stops, who was emailed, the serial numbers of the exchanged equipment, and where the associated equipment was sent for evaluation.Of note, it was stated there were no issues with the evaluated equipment.No photos or log files were submitted for review.Multiple attempts were made to obtain additional information from the customer regarding the event; however, no additional information was provided.The root cause for the reported event was unable to be conclusively determined through this analysis.Device history records could not be reviewed due to the serial number of the centrimag console being unknown.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 table 13 entitled ¿console alarms and alerts¿ addresses how to properly interpret and troubleshoot all system alarm.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: 18584095
• MDR Text Key: 334374187
• Report Number: 3003306248-2024-00028
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/20/2024

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: 201-90411
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/29/2023
• Initial Date FDA Received: 01/25/2024
• Supplement Dates Manufacturer Received: 04/26/2024
• Supplement Dates FDA Received: 05/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 1 MO
• Patient Sex: Male
• Patient Weight: 5 KG