MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II SYSTEM CONTROLLER; VENTRICULAR (ASSISST) 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	10/06/2021
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 had random beeping low voltage alarms, despite cleaning clips/connections and swapping to new equipment.The system controller was exchanged.
Additional Manufacturer Narrative
Main investigation conclusion.The reported event of atypical beeping and alarms on the system controller was able to be confirmed via review of the log file.The heartmate ii system controller (serial number: (b)(6) was returned for analysis; however, a log file was downloaded for review.A review of the downloaded log file showed events spanning approximately 17 days (b)(6) 2021 ¿ (b)(6) 2021 per timestamp).The controller recorded intermittent power cable disconnect alarms that were not associated with a power source exchange due to power cable faults, occurring on the black power cable.The power cable disconnect alarm activated with these events as well.All of the atypical power cable disconnects occurred while connected to battery power.These atypical alarms occurred at the time stamps of: (b)(6) 2021 at 06:45:55, 12:27:42, (b)(6) 2021 at 15:28:32 ¿ 15:39:26, (b)(6) 2021 at 12:24:04 ¿ 13:51:10, (b)(6) 2021 at 14:42:26, (b)(6) 2021 at 09:11:29 ¿ 09:11:57, (b)(6) 2021 at 18:00:58, intermittently on (b)(6) 2021 at 09:21:54 ¿ 12:40:53, (b)(6) 2021 at 18:36:35, (b)(6) 2021 at 22:42:07, (b)(6) 2021 at 15:37:29, (b)(6) 2021 at 14:06:40 ¿ 14:43:19, (b)(6) 2021 at 09:43:37, and on (b)(6) 2021 at 10:14:26.Multiple low voltage alarms were recorded throughout the log file which were caused by normal battery depletion.There were no other notable alarms active in the log file.Pump operation was not affected.The controller underwent preliminary and functional testing and passed.The controller was able to function as intended.The root cause of the reported event was unable to be conclusively determined through this investigation.Heartmate ii instructions for use, rev.C, section 7 entitled ¿alarms and troubleshooting¿ and heartmate ii patient handbook, rev.C, section 5 entitled ¿alarms and troubleshooting¿ addresses how to properly interpret and troubleshoot all system alarms including low voltage and power cable disconnect 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.The device history records were reviewed for the system controller (serial number: (b)(6) and was found to pass all manufacturing and qa specifications before being shipped to the customer.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE II SYSTEM CONTROLLER
• Common Device Name: VENTRICULAR (ASSISST) 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: 12738014
• Report Number: 2916596-2021-06084
• Device Sequence Number: 4920846
• Product Code: DSQ
• UDI-Device Identifier: 00813024013013
• UDI-Public: 00813024013013
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2021

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: 03/29/2024
• Device Model Number: 106762
• Device Catalogue Number: 10005080
• Device Lot Number: 7943522
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2021
• 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: 10/06/2021
• Supplement Date Received by Manufacturer: 11/23/2021
• Initial Report FDA Received Date: 11/02/2021
• Supplement Report FDA Received Date: 11/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/30/2021
• 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: 66 YR
• Patient Sex: Male
• Patient Weight: 75 KG