MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE SYSTEM MONITOR; Ventricular (assist) bypass

Model Number	1286INT
Medical Device Problem Code	Display Difficult to Read (1181)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of the system monitor displaying ¿no records obtained¿ could not be confirmed through this evaluation.It was reported, when trying to view the event log, the message ¿no records obtained¿ was displayed.The event log was unable to be viewed.A log file was retrieved and submitted for review.Data on (b)(6)2023 was reviewed.The controller event log file revealed no data was captured on the reported event date of (b)(6)2024.Additional information reported the message ¿no records obtained¿ issue resolved after the system monitor was rebooted.It was reported system monitor (serial # unavailable) will not be returned for evaluation.The root cause of the reported event could not be 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 serial number of the system monitor was unavailable, and the device history record could not be reviewed.Heartmate 3 instructions for use section 4 ¿ ¿system monitor¿ addresses how to properly use the system monitor, and the actions to take if the system monitor is not functioning as intended.This section also states how to view the system controller event history on the system monitor.Heartmate 3 patient handbook and heartmate 3 instructions for use caution the user 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.
Event or Problem Description
It was reported that the patient was readmitted to the hospital on (b)(6)2024 due to worsening arrhythmia symptoms.The arrhythmia was controlled; however, the patient remained hospitalized and underwent further examination as low flow was likely to occur.On (b)(6)2024, symptoms of a pulmonary embolism were noted, and extracorporeal membrane oxygenation (ecmo) was performed which was noted to be still ongoing.During ecmo management the heartmate 3 was barely working, with flow being 0-0.4 liters per minute and low flows constantly active.When the history was checked on the system monitor, it displayed "no records obtained," so it was decided to check whether the system was operating normally.Log files were submitted for review and captured low flow alarm events on (b)(6)2024 that occurred at times when pulsatility index (pi) was elevated.It was additionally reported that the patient experienced persistent ventricular fibrillation requiring defibrillation or cardioversion on (b)(6)2024, was admitted on (b)(6)2024 and had a history of arrhythmia prior to implant along with an implantable cardioverter defibrillator (icd).The arrhythmia was not thought to be device or therapy related and resolved.Additionally, on (b)(6)2024 the patient had respiratory failure which led to an invasive surgical procedure.It was noted that the patient also had respiratory failure on (b)(6)2024 with a ventricular septal defect (vsd) occurring and the patient requiring intubation for 9 days.The pulmonary embolism was diagnosed based on symptoms of pulmonary embolism.The patient had impaired pulmonary function, and their pulmonary arteries were narrow.The flow was declining under scrutiny to determine whether to change the speed of rotation etc.It was noted that the system monitor was rebooted after the message of "no records obtained', and since log files did not indicate any issue, no additional troubleshooting was performed.It was additionally reported on (b)(6)2025 that the cause of the respiratory failure was vsd.The vsd was closed prior to left ventricular assist device implant however was considered to have reopened.Even prior to implant the patient was noted to have a narrow pulmonary artery.It was noted that the patient had been admitted on (b)(6)2024 to an outside hospital and was direct current (dc) cardioversion defibrillation was performed.The patient was then admitted to the clinic on (b)(6)2024.The patient experienced decreased oxygen level, spo2 at 70%.On (b)(6)2024 the patient was intubated, but oxygenation did not improve.A computed tomography (ct) scan showed marked contraction of the pulmonary artery, and ecmo was performed.The patient was noted to be currently on ventilator in the ward.

• Brand Name: 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: 21396741
• Report Number: 2916596-2025-00758
• Device Sequence Number: 18473532
• Product Code: DSQ
• UDI-Device Identifier: 00813024010142
• UDI-Public: (01)00813024010142
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P160054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 02/16/2025

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: 1286INT
• Device Catalogue Number: 1286INT
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2025
• Initial Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 68 YR
• Patient Sex: Male
• Patient Weight: 50 KG