MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG 1ST GENERATION PRIMARY CONSOLE; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number	102954
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.
Event or Problem Description
It was reported that the patient was on support for extra corporeal membrane oxygenation.The most recent circuit change was approximately 17 days prior to the event.The patient had been off of anticoagulation throughout ecmo course due to bleeding.The patient was not on heparin drip.On (b)(6) 2022 the patient was at 1100 and the motor was reported to be hot to the touch with no alarms.The team switched to full backup battery system.On (b)(6) 2022 the motor was still hot but as not as hot as the previous.A plan was made to not switch anything and to continue to monitor the patient.A large circuit change was considered but the patient was dependent on ecmo.Rotations per minute were at 5300 on the current system and the previous one switched out.Speeds on 5500 rpm were unable to be obtained.The motor would be returned for evaluation.
Event or Problem Description
Related manufacturer report number: 3003306248-2022-00014.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of the motor overheating and not reaching 5500 rpms was not confirmed.The centrimag 1st generation primary console was not returned for analysis.Multiple good faith efforts were sent to retrieve additional information including the serial number of the centrimag 1st generation primary console and if anything would be returning for evaluation; however, no response was received.The root cause for the reported event was unable to be conclusively determined through this analysis.Centrimag motor instructions for use (rev.G) instructs to always have a back-up centrimag motor available.Centrimag blood pump instructions for use (rev.E) states "always have a spare centrimag blood pump, back-up console and equipment available for change out." centrimag primary console operating manual (rev.I) warns "one back-up console and motor are required in the immediate vicinity of each patient whenever the centrimag blood pump is used.The back-up console must be connected to the back-up motor, 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 primary console or primary motor experience a malfunction.".No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG 1ST GENERATION PRIMARY CONSOLE
• Common Device Name: 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: 13506213
• Report Number: 3003306248-2022-00015
• Device Sequence Number: 17159578
• Product Code: DWA
• UDI-Device Identifier: 07640135140672
• UDI-Public: 07640135140672
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K093832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2022

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
• Operator of Device: Health Professional
• Device Model Number: 102954
• Device Catalogue Number: 102954
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2022
• Supplement Date Received by Manufacturer: 03/04/2022
• Initial Report FDA Received Date: 02/10/2022
• Supplement Report FDA Received Date: 03/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown