MAUDE Adverse Event Report: THORATEC CORPORATION HMII, G2.3, POCKET CONTROLLER; HEARTMATE II SYSTEM CONTROLLER

Model Number	10005080
Medical Device Problem Codes	Disconnection (1171); Electrical Power Problem (2925)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient had many low voltage alarms on their log file history.The battery clips were less than 1 year old and looked clean.The batteries were 3 years old.The battery clips were replaced and the new batteries were used with the patient's old battery clips, however; the controller power immediately dropped from 4 to 3 bars.Another attempt was made using new batteries and new battery clips and the power remained at 4 bars.A review of the log file revealed 3 transient low voltage alarms.Two occurred on (b)(6) 2022 at 1612 and one occurred on (b)(6) 2022 at 1618.All while the patient was tethered on batteries.The patient stated they continued to hear alarms after the battery and clips were exchanged.A controller exchange was performed on (b)(6) 2022 and the alarms resolved.
Additional Manufacturer Narrative
The reported events of atypical low voltage and power cable disconnect alarms were able to be confirmed via review of the log file.The heartmate ii system controller serial number: (b)(4).Was not returned for analysis; however, log files were submitted for review.A review of the submitted log files showed overlapping events spanning approximately 19 days (27feb2022 ¿ 18mar2022 per timestamp).Atypical low voltage hazard alarms were active on 10mar2022 at 16:12:28 ¿ 16:12:32.The rsoc voltages suddenly dropped to ~1.8v on the white power cable and 0v on the black power cable at 16:12:28 and then suddenly jumped up to 3.0v and 3.8v on the white and black power cables, respectively, at 16:12:32.The alarms occurred again on 11mar2022 at 16:18:20.The alarms cleared shortly after activating.The controller recorded intermittent power cable disconnect alarms that were associated with a power source exchange due to power cable faults, occurring on the white power cable.The power cable disconnect alarm activated with these events as well.None of the atypical power cable disconnects occurred during power source exchanges.These atypical alarms occurred intermittently at the time stamps of 16mar2022 from 10:50:12 ¿ 11:03:30, on 17mar2022 from 19:29:15 ¿ 21:16:36, and on 18mar2022 from 05:03:32 ¿ 09:46:17.The alarms cleared shortly after activating.There were no other notable alarms active in the log file.Pump operation was not affected.Additional information provided on 21mar2022.Stated that the alarms resolved after the controller exchange, and that no product will be returning.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.Heartmate ii patient handbook, rev.C, section 6 "caring for the equipment" describes how to care for and clean all equipment, including the 14v battery clips and 14v batteries.Section 10, entitled ¿safety checklists¿, provides checklists to assist the patient in performing routine maintenance of heartmate ii lvad, including the 14v battery clips and 14v batteries.The heartmate ii patient handbook, rev.C, section 2 ¿how your heart pump works¿) tells users that two fully charged 14-volt batteries are expected to power the system for approximately 10-12 hours, which can vary depending on activity level.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)(4)) and was found to pass all manufacturing and qa specifications before being shipped to the customer on (b)(6) 2018.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HMII, G2.3, POCKET CONTROLLER
• Common Device Name: HEARTMATE II SYSTEM CONTROLLER
• 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: 13894774
• Report Number: 2916596-2022-01880
• Device Sequence Number: 14650921
• Product Code: DSQ
• UDI-Device Identifier: 00813024013013
• UDI-Public: 00813024013013
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/24/2022

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 Expiration Date: 08/21/2021
• Device Model Number: 10005080
• Device Catalogue Number: 10005080
• Device Lot Number: 6562835
• 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: 03/18/2022
• Initial Report FDA Received Date: 03/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/22/2018
• 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: 72 YR
• Patient Sex: Male
• Patient Weight: 74 KG