MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 SYSTEM CONTROLLER; VENTRICULAR (ASSISST) BYPASS

Model Number 106531US

Device Problems Disconnection (1171); Display Difficult to Read (1181)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/19/2021

Event Type  malfunction  

Manufacturer Narrative

Patient weight was requested but not provided.No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.

Event Description

Related manufacturer reference number: 2916596-2021-07153.It was reported that log files were sent in for review due to alarms on the mobile power unit (mpu).There were power cable issues overnight on 19nov2021 and 20nov2021.The patient reported alarms while on the mpu and saw red lights next to battery cables as well as driveline.The patient switched to batteries after the alarm and remained on battery for the rest of the night.There were no alarms on the controller history or interrogation, aside from the power cable disconnects.The log file review found a few unusual power cable disconnect events while connected to battery power on (b)(6) 2021.It was indicated that the patient switched to the mobile power unit on (b)(6) 2021 at 0:13:57.Over the next 15 minutes, the log data recorded a couple of power cable disconnect events that did not appear to be intentional.It also indicated that the alarm silence button was pressed a few times during this period.The alarms resolved after the controller was exchanged.The controller was exchanged due to a dim pump running light.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of a dim pump running led on the heartmate 3 system controller was confirmed via the returned system controller.The heartmate 3 system controller (serial number (b)(6) was returned to abbott burlington for analysis.The returned controller was connected to a mock loop and a log file was downloaded.The submitted log file (labeled 095121) and the downloaded log file (labeled ab301212) contained partially overlapping data spanning approximately 3 days (b)(6) 2021 per the timestamp).Additional events were captured on (b)(6) 2021; however, this is consistent with data captured when the system controller was returned to abbott burlington.The heartmate 3 system controller was returned to abbott burlington for analysis.During the evaluation, the system controller underwent a controller self-test.During this time, it was observed that the green pump running led was dim.Provided information stated that the controller was changed in the clinic due to very dim green pump running light emitting diode (led).The root cause of the reported event could not be determined; however, there is a corrective action for this issue.The device history records were reviewed and the records revealed the heartmate 3 system controller (serial#: (b)(6) was manufactured in accordance with manufacturing and qa specifications.The heartmate 3 system controller (serial#: (b)(6) was shipped from abbott on 05jul2018.Heartmate iii patient handbook (rev.C), under section 5 ¿alarms and troubleshooting¿ and heartmate iii instructions for use (ifu) (rev.C), under section 7 ¿alarms and troubleshooting¿ cover all alarms (visual and audible), including the power cable disconnect alarm conditions, and the actions to take if the alarms cannot be resolved.Heartmate iii instructions for use (rev.C) section 8 entitled ¿caring for the equipment¿ and heartmate iii patient handbook (rev.B) section 6 entitled ¿caring for the equipment¿ addresses how to properly care for, maintain, and store the equipment for proper use.Heartmate iii patient handbook (rev.C) and heartmate iii instructions for use (ifu) (rev.C) caution 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: HEARTMATE 3 SYSTEM CONTROLLER
• Type of Device: 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: 12983749
• MDR Text Key: 286861166
• Report Number: 2916596-2021-07154
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013235
• UDI-Public: 00813024013235
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/14/2022

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/15/2021
• Device Model Number: 106531US
• Device Catalogue Number: 106531US
• Device Lot Number: 6512840
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/22/2021
• Initial Date FDA Received: 12/13/2021
• Supplement Dates Manufacturer Received: 02/08/2022
• Supplement Dates FDA Received: 02/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/16/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Sex: Male