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

Model Number	106762
Medical Device Problem Code	Electrical Power Problem (2925)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.
Event or Problem Description
It was reported that the patient's log file captured several odd low power alarms when connected to batteries.It was requested that the batteries and battery clips be checked for integrity and cleaned with an alcohol wipe.The log file also noted a few unsustained pump power/ pump flow elevations between 04oct2022 and 06oct2022.There were no other unusual events recorded in the log file event history.The equipment was operating as intended.The patient's system controller was exchanged due to a low battery alarm while connected to batteries with 3 bars of charge.The patient stated that the batteries have been calibrated recently and their battery clips were in good shape visually.The alarms resolved after the system controller exchange.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the report of low power alarms when connected to batteries was confirmed via the log file.The system controller (serial #: (b)(6)) was not returned for analysis; however, the log file was submitted for review with events spanning approximately 14+ days (29 sep 2022 ¿ 13 oct 2022 per timestamp).Decreased relative state of charge (rsoc) and bus voltages were observed on both power cables while connected to the 14v batteries.While connected to battery power, the rsoc/bus voltages fluctuated and dropped below the low voltage thresholds, activating low voltage advisory/hazard alarms; the low voltage hazard alarms bypassed the low voltage advisory alarms multiple times due to the bus voltage dropping to depleted battery voltages.The pump operation was not affected.The pump maintained speeds above the low speed limit throughout the log file.Multiple attempts were made to obtain additional information from the customer regarding the event, including the product return status.However, to date, the system controller (serial #: (b)(6)) was not returned for analysis.Per account information received on 17jan 2023, the product was lost in transit.As a result, the file will be closed with no further action.The exact cause of the reported event was unable to be conclusively determined during this investigation.The device history records were reviewed for the system controller (serial #: (b)(6)) and the system controller was found to pass all manufacturing and quality assurance (qa) specifications before being shipped to the customer.Heartmate ii patient handbook (rev.C) section 5, entitled ¿alarms and troubleshooting¿, and heartmate ii instructions for use (ifu) (rev.C) section 7, entitled ¿alarms and troubleshooting¿, cover all alarms (visual and audible), including the low voltage advisory/hazard alarm conditions, and the actions to take if the alarms cannot be resolved.Heartmate ii patient handbook (rev.C) section 6, entitled "caring for the equipment", describes how to care for and clean all equipment, including the system controller, system controller power cables, 14v batteries, battery clips.Section 10, entitled ¿safety checklists¿, provides checklists to assist the patient in performing routine maintenance of heartmate ii lvad, including inspecting the system controller power cables for dirt, grease, or damage.Heartmate ii patient handbook (rev.C) cautions 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: HEARTMATE II SYSTEM CONTROLLER
• 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: 15711114
• Report Number: 2916596-2022-14562
• Device Sequence Number: 17799788
• Product Code: DSQ
• UDI-Device Identifier: 00813024012528
• UDI-Public: 00813024012528
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2023

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: 12/31/2020
• Device Model Number: 106762
• Device Catalogue Number: 105109
• 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: 10/13/2022
• Supplement Date Received by Manufacturer: 01/18/2023
• Initial Report FDA Received Date: 11/01/2022
• Supplement Report FDA Received Date: 01/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2017
• 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: 63 YR
• Patient Sex: Female
• Patient Weight: 124 KG