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

Model Number	106762
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of damaged power cables and fluid ingress was not confirmed.The hm2 system controller, serial (b)(4), was not returned for analysis.Per provided information, the controller had a damaged power cable from usual usage and had a fluid ingress from a pin point hole.The exchanged controller will not be returned.A root cause of the reported event was not determined through this analysis.Device history records were reviewed and showed no deviations from manufacturing or qa specifications.(b)(4) was shipped to the customer on 04oct2019.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.Heartmate ii instructions for use section 7-¿alarms and troubleshooting¿ and heartmate ii patient handbook section 5-¿alarms and troubleshooting¿ explain how to properly interpret and troubleshoot alarms including power cable disconnect.Heartmate ii instructions for use section 8-¿equipment storage and care¿ and heartmate ii patient handbook section 6-¿caring for the equipment¿ explain how to properly maintain the integrity of the system controller, and state how to store, transport, and maintain the system controller to prevent damage.No further information was provided.The manufacturer is closing the file on this event.
Event or Problem Description
It was reported that the patient was seen in clinic on (b)(6) 2021.It was noted that the patient had multiple advisory alarms.Low voltage on (b)(6) 2021.The patient stated that this happens on a specific set of batteries.The batteries were exchanged.The patient's controller was also showing wear, green liquid was coming out of a pinpoint hole.The controller was exchanged.A log file was sent in for review which found a low speed advisory on (b)(6) 2021.There was not enough evidence to confirm the cause of the speed drop.Possible causes are something that passed through the pump or would indicate a driveline issue.The log file also confirmed a low battery advisory on (b)(6) 2021 due to the patient waiting too long to replace the batteries.There were no other notable alarm conditions in the log file.No additional information was provided.

• Brand Name: HEARTMATE II SYSTEM CONTROLLER
• Common Device Name: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 11577008
• Report Number: 2916596-2021-01460
• Device Sequence Number: 4352640
• Product Code: DSQ
• UDI-Device Identifier: 00813024013013
• UDI-Public: 00813024013013
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P060040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/26/2021

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: 06/05/2021
• Device Model Number: 106762
• Device Catalogue Number: 10005080
• Device Lot Number: 6540391
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2021
• Initial Report FDA Received Date: 03/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1