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

Model Number 201-90411

Device Problem Insufficient Information (3190)

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

Event Date 09/05/2023

Event Type  malfunction  

Manufacturer Narrative

Related mfr numbers: motor mfr pump mfr 2916596-2023-07077.No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.

Event Description

It was reported that the flow probe was not functioning properly, and the monitor display was scrambled.A system alert s3 was noted, and the clinician stated that the console would not read the flows.The only display for flow was a dash mark.The clinician changed out the flow probe and received the same message and also put the flow probe on another console and it was able to read the flow.Per the clinician, the problem was not with the flow probe.Additionally, it was communicated that there was a slight adverse patient impact, and the action taken was to change out the console.The flows were decreased for a few seconds while the console and motor were changed out.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of an s3: system fault alarm with a blank flow value was confirmed.A log file was extracted from the returned centrimag console and was reviewed.The system was observed to be operating at ~5200 rpm / 6.3 lpm on (b)(6) 2023.An s3: system fault alarm was observed on (b)(6) 2023 correlating to a communication-related sub-fault.The flow value was observed to be 0 lpm after this point as a result of this sub-fault.The console was observed to have been exchanged within the same minute without shutting down, and the system¿s speed was ramped back up to its original set speed within ~1 minute.No other notable events were observed.The returned centrimag console was functionally tested at the service depot alongside the other returned centrimag equipment and in isolation.Atypical events were unable to be reproduced throughout all testing, and the console functioned and operated a mock loop as intended.The centrimag 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 the centrimag console showed the device was manufactured in accordance with manufacturing and qa specifications.The 2nd generation centrimag system operating manual 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 12.1-"appendix i ¿ console alarms and alerts" contains a list of console alarms and alerts, including s3 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
• 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: 17821787
• MDR Text Key: 324331252
• Report Number: 3003306248-2023-05076
• 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: 11/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2023
• 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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Sex: Male
• Patient Weight: 107 KG