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

Model Number	106762
Medical Device Problem Codes	Mechanical Problem (1384); Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2023
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 presented to the clinic with a tear on the black power cable for their heartmate ii system controller.Upon hooking the patient up to the monitor, the monitor would not register that the controller was connected and therefore the log files couldn't be downloaded.A second monitor was tried without success.There was no damage noted on the patient's white power cable or driveline.The patient denied knowing about any damage to the cable and thought the damage had occurred during the night.The controller was replaced.
Event or Problem Description
Replacing the controller resolved the data transfer and monitor display issue.
Additional Manufacturer Narrative
Incidental findings: power cable disconnect alarms: ¿a review of the log file revealed on (b)(6) 2023 at 11:25:52, 12:37:18, 12:41:56, and 20:16:01 ¿ 20:18:23, and 22jul2023 at 12:29:45 and 12:33:54, while connected to batteries, intermittent power cable disconnect alarms were active due to black power cable faults associated with the power cable being outside the expected voltage range.No external power alarm due to an atypical power cable disconnect alarm: ¿on (b)(6) 2023 at 12:41:56, a no external power alarm activated due to a true white power cable disconnect during an atypical black power cable disconnect event.¿ manufacturer's investigation conclusion: the reported event of a tear in the black power cable and no communication with the system monitor was confirmed via evaluation.A review of the log file contained data spanning approximately 21 days ((b)(6) 2023 per timestamp).The log file showed that the pump operated as intended despite the reported damage to the system controller.An image of heartmate ii system controller (s/n: (b)(6)) was submitted for review and the tear in the black power cable was confirmed.The system controller was returned for analysis and the black power cable damage was observed.Upon connecting to the controller to the system monitor, there was no communication.The power cables underwent continuity and insulation testing and did not pass.The power cables were cut open to inspect the condition of the wires and the white power cable¿s orange wire (transmission communication) was found to be broken.Additionally, the black power cable¿s orange wire (unused line) was broken at the site of the reported damage.No other wire damage was observed.The controller¿s power cables were replaced with test power cables in order to continue evaluation.The system controller was functionally tested and passed.The controller was connected to a mock circulatory loop for an extended period and was able to operate as intended.The root cause for no communication with the system monitor was determined to be damage to the white power cable¿s communication wire.A root cause for the black power cable damage was unable to be conclusively determined through this analysis.The heartmate ii patient handbook, rev.C, section 10 ¿safety checklists¿) instructs users to regularly inspect their equipment for damage, including damage to the system controller¿s power cords, and to obtain replacements if needed.Heartmate ii instructions for use, rev.C, section 7 - ¿alarms and troubleshooting¿ and heartmate ii patient handbook, rev.C, section 5 - ¿alarms and troubleshooting¿ explain how to properly interpret and troubleshoot all alarms.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.Device history records were reviewed and showed no deviations from manufacturing or quality assurance (qa) specifications.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: 17550802
• Report Number: 2916596-2023-05731
• Device Sequence Number: 6939578
• Product Code: DSQ
• UDI-Device Identifier: 00813024013013
• UDI-Public: 00813024013013
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 11/01/2023

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: 04/09/2024
• Device Model Number: 106762
• Device Catalogue Number: 106762
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2023
• 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: 07/28/2023
• Supplement Date Received by Manufacturer: 10/25/2023
• Initial Report FDA Received Date: 08/15/2023
• Supplement Report FDA Received Date: 11/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2022
• 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: 78 YR
• Patient Sex: Female
• Patient Weight: 63 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White