MAUDE Adverse Event Report: THORATEC CORPORATION THORATEC® HEARTMATE®, SYSTEM MONITOR; VENTRICULAR (ASSIST) BYPASS

Model Number	1286A-US
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that system monitor showed the emergency backup battery (ebb) in the primary system controller needed to be replaced as it was expiring.However, when looking at the battery data it stated the battery expired in 33 months.The ebb was reseated, and self-test was done.The monitor was still showing the ebb expiring.Log files captured both of the times the ebb was reseated.Since the monitor was used was the old one, it was recommended to turn it off and wait about 15 seconds and let the capacitors discharge.The monitor was restarted and that resolved the issue.No equipment was exchanged.
Additional Manufacturer Narrative
Section d4: expiration date and manufacture date (h4) cannot be determined.The primary udi number in d4 is reflective of all available information.No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.
Additional Manufacturer Narrative
Section d4, primary udi number: updated.Manufacturer's investigation conclusion: the reported event of an inaccurate backup battery expiring message displayed on the heartmate system monitor was confirmed through provided images.Provided information indicated that restarting the system monitor resolved the erroneous message displayed.The monitor remained in use until the scheduled transition to the heartmate touch device on (b)(6) 2024; to date the monitor has not been returned.A root cause for the reported event was not conclusively determined through this analysis.Although the system monitor was not returned for evaluation, a corrective and preventative action (capa) was opened to further investigate issues related to the system monitor atypical screen behavior.The device history records were reviewed and the records reveals that the heartmate system monitor, serial number (b)(6) , was manufactured in accordance with manufacturing and qa specifications.The heartmate power module instructions for use (rev.B) was available for use at the time of the event.Section 2 entitled ¿setting up the power module (pm) prior to use¿ covers set up and use of the system monitor with the power module.The heartmate 3 patient handbook (rev.D) was available for use at the time of the event and cautions the users to call their hospital contacts if they think, for any reason, any portion of their equipment is not functioning as usual, is broken, or they are uncomfortable with the operation of the equipment.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: THORATEC® HEARTMATE®, SYSTEM MONITOR
• Common Device Name: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer Contact: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 19667506
• Report Number: 2916596-2024-04087
• Device Sequence Number: 7017288
• Product Code: DSQ
• UDI-Device Identifier: 00813024010852
• UDI-Public: (01)00813024010852(11)121101
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P160054
• 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
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2024

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
• Operator of Device: Lay User/Patient
• Device Model Number: 1286A-US
• Device Catalogue Number: 1286A-US
• 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: 06/14/2024
• Supplement Date Received by Manufacturer: 08/16/2024
• Initial Report FDA Received Date: 07/03/2024
• Supplement Report FDA Received Date: 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2012
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: FA-Q224-HF-1
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 89 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White