MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG 2ND GENERATION PRIMARY CONSOLE WITH EM-TEC ADULT FLOW PROBE (VAS/ECMO); CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 102954

Device Problems Electrical Power Problem (2925); Unexpected Shutdown (4019)

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

Event Date 09/08/2023

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

It was reported that the centrimag pump stopped working.An exchange was undertaken within 5 minutes.No patient injury was reported.Motor mfr # 3003306248-2023-05078.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of the centrimag system stopping atypically was not confirmed; however, flow- and pressure-related alarms that prompted an equipment exchange were confirmed via the log file that was extracted from the returned centrimag console (serial number (b)(6) ).The system was observed to be operating around ~3200 rpm / 3.0 lpm on the reported event date of 08sep2023.On 08sep2023, multiple alarms regarding the patient¿s flow and pressure values became active (f3: flow below minimum, p4: pressure 1 below minimum, p5: pressure 2 below minimum).The patient¿s flow values decreased to approximately ~2.0 lpm during this time; however, the motor remained operational at ~3200 rpm.The patient¿s set speed was manually ramped down to ~2450 rpm approximately 2 minutes later, and the patient¿s flow value was ~0.8 lpm at this time.Then, the set speed was observed to have been manually ramped down to 0 rpm approximately 2 more minutes later to perform the reported equipment exchange.The console was not observed to be in patient use after this time.No other notable events were observed.The returned centrimag console was functionally tested at the european distribution center and was found to perform as intended, and atypical events were unable to be reproduced throughout all testing.Preventive maintenance was performed, and the serviced and tested console was returned to the customer site after passing all tests per procedure.The root cause of the reported event was unable to be conclusively determined through this analysis.Review of the device history record for centrimag console, serial number (b)(6), showed the device was manufactured in accordance with manufacturing and qa specifications.The 2nd generation centrimag system operating manual (rev.L) section 3 "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.L) section 11.1-"appendix i ¿ console alarms and alerts" contains a list of console alarms and alerts, including flow- and pressure-related alarms, 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 WITH EM-TEC ADULT FLOW PROBE (VAS/ECMO)
• 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: 17747133
• MDR Text Key: 323423659
• Report Number: 3003306248-2023-05079
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 07640135140702
• UDI-Public: 7640135140702
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K093832
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/28/2023

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: 102954
• Device Lot Number: 6525865
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/08/2023
• Initial Date FDA Received: 09/14/2023
• Supplement Dates Manufacturer Received: 12/14/2023
• Supplement Dates FDA Received: 12/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2018
• 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