MAUDE Adverse Event Report: THORATEC CORPORATION THORATEC® HEARTMATE II®, SYSTEM CONTROLLER, US, EP; VENTRICULAR (ASSIST) BYPASS

Model Number	103696
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Related mfr # 2916596-2023-07388.It was reported that the patient passed away due to a fall.The patient also had red heart alarms.Death was considered related to the heartmate ii system controller.
Additional Manufacturer Narrative
D4: missing controller serial number.This was requested but not provided.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.
Additional Manufacturer Narrative
No further information was provided.The manufacturer is closing the file on this event.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of red heart alarms was confirmed via log file analysis.A log file was downloaded for review.Prior to a clock reset in the log file, the data spanned approximately 11 days (day 541 hour 18 minute 22 ¿ day 551 hour 19 minute 38 per timestamp).On day 551 hour 3 minute 6, a power source exchange was captured; however, due to the controller software, the external power source was unable to be conclusively determined.From the power source exchange until day 551 hour 19 minute 38, the bus voltage slowly decreased.As the bus voltage reached 13.6v, a low battery advisory activated, causing a yellow battery warning light.Within the same minute, the alarms transitioned into low battery hazard alarms and a red battery warning light.At an unknown time, the system lost external power and the pump stopped.Of note, if the system controller does not receive power, a continuous audio tone activates, but no warning lights.Red heart alarms were triggered once the system reconnected to power during the ongoing pump stop.The pump regained speeds above the low speed limit shortly after restarting, resolving the alarms.Until the end of the log file, the pump was restarted 3 times due to the system intermittently losing external power, consistent with both power cables being disconnected.The heartmate ii system controller, us, ep (s/n: (b)(6)) was returned for analysis.The system controller underwent functional testing and passed without issue.The controller was connected to a mock loop and was able to operate a pump without issue for extended operation.Red heart alarms were not reproduced throughout testing.Per the provided information, the patient fell, and red heart alarms were active.It was unknown if the fall was mechanical or induced by left ventricular assist device (lvad) therapy.A root cause for the reported event was unable to be conclusively determined through this analysis.The heartmate ii lvas instructions for use, rev.D, section 12.4 entitled ¿alarms screen¿ and heartmate ii lvas patient handbook, rev.D, section entitled ¿display module¿ describe all system alarms and the steps suggested to resolve each of them, including those associated with red heart alarm conditions.Heartmate ii patient handbook, rev.D, section entitled ¿important warnings¿ explains that at least one system controller power lead must be connected to a power source at all times.If both power leads are disconnected at the same time, your pump will stop.The heartmate ii lvas instructions for use, rev.D, section 14.2, entitled ¿initializing the system controller¿, states that this battery module enables the system controller alarm to sound if the system controller loses power while connected to a patient.It is also noted that the battery module does not provide backup power to the pump.The heartmate ii lvas patient handbook, rev.D, section entitled ¿heartmate batteries¿ states that one pair of new heartmate 14 volt li-ion batteries will provide six to ten hours of support.The patient handbook, rev.D, also 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.Device history records were reviewed and showed no deviations from manufacturing or qa specifications.No further information was provided.The manufacturer is closing the file on this event.
Additional Manufacturer Narrative
Section g1: updated information.Section d1: corrected.Section d4, catalog number: corrected.Section d4, primary udi number: corrected.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: THORATEC® HEARTMATE II®, SYSTEM CONTROLLER, US, EP
• 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: 18040731
• Report Number: 2916596-2023-07444
• Device Sequence Number: 17999018
• Product Code: DSQ
• UDI-Device Identifier: 00813024010630
• UDI-Public: (01)00813024010630(17)220312
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P060040
• 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 Practitioner
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/24/2024

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 Expiration Date: 03/12/2022
• Device Model Number: 103696
• Device Catalogue Number: 103696
• Device Lot Number: 6898585
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2023
• Supplement Date Received by Manufacturer: 01/24/2024; 03/18/2024; 05/13/2024
• Initial Report FDA Received Date: 10/31/2023
• Supplement Report FDA Received Date: 01/30/2024; 04/09/2024; 05/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/12/2019
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 85 YR
• Patient Sex: Female
• Patient Weight: 62 KG