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

Model Number	103696
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Manufacturer's investigation conclusion: the reported event of audio issues with the system controller was not confirmed.A review of the submitted log file spanned approximately 15 hours (day 69 hour 5 minute 58 ¿ day 69 hour 20 minute 52 per time stamp).Throughout the entire log file while the controller was connected to batteries, the low voltage advisory alarm was active due to rsoc voltages fluctuating outside the expected voltage range on both power cables.The alarm did not affect the controller's ability to operate the pump at the set speed.No other notable alarms were active in the log file.The system controller, serial number (b)(4), was not returned for analysis and remains in use.Additional information provided on (b)(6) 2022 stated that low voltage advisory alarms were recorded, but the patient was not aware of the alarms.The heartmate ii instructions for use section b -¿technical specifications¿ explains that the correct audio level specification for controller advisory and hazard alarms is ~85 db.A root cause for the reported event was due to user error by disconnecting both power cables simultaneously.Device history records were reviewed and showed no deviations from manufacturing or qa specifications.The patient handbook 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.Heartmate ii instructions for use section b -¿technical specifications¿ explains that the correct audio level specification for controller advisory and hazard alarms is ~85 db.No further information was provided.The manufacturer is closing the file on this event.
Event or Problem Description
It was reported that the patient had low voltage advisories without a power supply replacement.The low voltage advisory occurred frequently while connecting the battery.The patient has previously had battery clips, power module cables, and controllers replaced in october but the low voltage advisories have persisted.Previous log file analysis suggested battery calibration but the battery charger didn't show calibration while charging.The low voltage advisories were occurring frequently so the batteries were replaced.It was later stated that the low voltage advisory alarms did not sound so the patient was unaware of alarms.Although it had just been an hour or two since the battery exchange, occasional low voltage advisory alarms were recorded again.The battery clips were replaced, the controller was replaced but the alarms continued.On hospital visit on (b)(6) 2022 battery failure was suspected and the patient was given hospital-owned batteries to try and resolve the issue.On following visit on (b)(6) 2022 the issue continued and was attributed to battery clip failure from clips replaced in august.The four clips were replaced with new ones and will be returned for analysis.

• Brand Name: 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: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 16444857
• Report Number: 2916596-2023-01281
• Device Sequence Number: 17525636
• Product Code: DSQ
• UDI-Device Identifier: 00813024010630
• UDI-Public: 00813024010630
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P060040
• 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
• Type of Report: Initial
• Report Date (Section B): 02/27/2023

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: 03/24/2020
• Device Model Number: 103696
• Device Catalogue Number: 103696
• 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: 02/22/2023
• Initial Report FDA Received Date: 02/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2017
• 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: 35 YR
• Patient Sex: Female
• Patient Weight: 54 KG