MAUDE Adverse Event Report: THORATEC CORPORATION HMII, G2.3, POCKET CONTROLLER; VENTRICULAR (ASSISST) BYPASS

Model Number	10005080
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2021
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 controller self test did not sound as expected.The patient noticed this issue as well.The controller was exchanged due to this issue.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of the system controller speakers not sounding as expected when performing a self-test was not confirmed.The heartmate ii system controller (serial #: (b)(6) was returned for analysis and a log file was downloaded that spanned approximately 4 days (b)(6) 2021 per timestamp).There were no notable alarms in the log file.Pump operation was not affected.The heartmate ii system controller was able to pass all preliminary and functional testing.The heartmate ii system controller was connected to a mock loop and was able to operate as intended.During further testing the system controller speakers were placed 10 cm away from a sound meter.A self-test was activated on the system controller and the alarms measured over the expected 85 db measurement and the alarms did not sound unusual.The speakers did not have any debris present in them.The reported event was not reproduced.The root cause of the reported event was unable to be conclusively determined in this analysis.The device history records were reviewed and the records revealed the heartmate ii system controller (serial#: (b)(6) was manufactured in accordance with manufacturing and qa specifications prior to being initially shipped outbound on 07apr2020.Heartmate ii instructions for use section 7 entitled ¿alarms and troubleshooting¿ and heartmate ii patient handbook section 5 entitled ¿alarms and troubleshooting¿ addresses how to properly interpret and troubleshoot all system alarms.Heartmate ii instructions for use section 8 entitled ¿equipment storage and care¿ and heartmate ii patient handbook section 6 entitled ¿caring for the equipment¿ addresses how to properly care for, maintain, and store the equipment for proper use.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.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HMII, G2.3, POCKET CONTROLLER
• Common Device Name: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 12059170
• Report Number: 2916596-2021-03047
• Device Sequence Number: 17038421
• Product Code: DSQ
• UDI-Device Identifier: 00813024013013
• UDI-Public: 00813024013013
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2021

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: 01/30/2023
• Device Model Number: 10005080
• Device Catalogue Number: 10005080
• Device Lot Number: 7313521
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/26/2021
• Supplement Date Received by Manufacturer: 07/29/2021
• Initial Report FDA Received Date: 06/24/2021
• Supplement Report FDA Received Date: 07/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 93