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

Model Number L201-90411

Device Problem Electrical Power Problem (2925)

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

Event Date 01/11/2022

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 a short was experienced with a rental centrimag and console system.A pump head alarm and motor disconnect alarm was heard after the patient was prepared for transport for an urgent computed tomography (ct) scan.The connections were all evaluated to be appropriately fitted and secured which took about 2 minutes for the pump/motor to allow for restoration of flow.At time of the event there was no active touching of the device prior to alarm or loss of flows.

Event Description

Related manufacturer reference number: 3003306248-2022-00003.

Manufacturer Narrative

Manufacturer's investigation conclusion: incidental findings: damaged console/monitor connector cable.The reported events of an atypical alarm and the system stopping with an active m2: motor disconnected alarm were both confirmed via the log file that was extracted from the returned centrimag console (serial number (b)(6)) during testing.On the reported event date of (b)(6) 2022, the system was observed to be operating around ~3600 rpm / 3.6 lpm.At 1:16 on this date, an m4: motor alarm was observed.The system was observed to have been temporarily stopped with an active m2: motor disconnected alarm within the same minute after the m4 alarm was muted, and both motor alarms cleared and did not reoccur after the system was ramped back up to ~3600 rpm / 3.6 lpm at 1:19.The system was observed to have been manually shut down at 1:42 of the same day and was not observed to have been in patient use throughout the remainder of the data.The returned centrimag console was received at the service depot, and the console was tested alongside all returned equipment (centrimag motor (b)(6), flow probe 138824, and the monitor cable [lot number unknown]).The system operated for an extended period, and atypical events and alarms were unable to be reproduced throughout all testing.A full functional checkout was performed, and the serviced and tested console was returned to the rental pool after passing all tests per procedure.The root causes of the reported events were unable to be conclusively determined through this analysis.Review of the device history record for the 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 section 3 "about the 2nd generation centrimag primary console" 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 entitled "appendix i ¿ console alarms and alerts" contains a list of console alarms and alerts, including m2 and m4 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 RENT
• 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: 13343309
• MDR Text Key: 290542778
• Report Number: 3003306248-2022-00002
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 07640135140702
• UDI-Public: 07640135140702
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/08/2022

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 Expiration Date: 03/12/2023
• Device Model Number: L201-90411
• Device Catalogue Number: 201-90411
• Device Lot Number: 7790236
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/11/2022
• Initial Date FDA Received: 01/25/2022
• Supplement Dates Manufacturer Received: 02/15/2022
• Supplement Dates FDA Received: 03/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/18/2019
• 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: 46 YR
• Patient Sex: Female
• Patient Weight: 73 KG