MAUDE Adverse Event Report: THORATEC CORPORATION SYSTEM CONTROLLER, HM 3, LOW FLOW 2.0; HEARTMATE 3 CONTROLLER

Model Number	106531LF2
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2021
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 device had zero flow on low flow controller.Log file analysis contained a sudden drop in estimated flow starting @11:36am on (b)(6) 2021 until the end of this log file @1:23pm on (b)(6) 2021.The patient was reported as doing okay, flows were back and the patient got admitted for a computed tomography angiography (cta).The controller and modular cable were swapped and this appeared to have resolved the alarms.The cta was performed on (b)(6) 2021 due to contrast allergy and patient needed admission for steroids premed.Related mfr.Report numbers: 2916596-2021-04161 and 2916596-2021-04216.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of the flow decreasing to 0 lpm can be confirmed based on the information recorded in the log files.The data log files were successfully retrieved from the returned system controller serial number (b)(6).The event log file contained data recorded on (b)(6) 2021 from 2:33 am to 1:46 pm.The recorded information revealed the system maintained the set speed with no interruptions, the recorded flow ranged between 3.7-4.7 lpm, the recorded power was around 4.5w and the pi was 3.4-10.4.The data captured at 11:36 am revealed that the flow decreased to 0 lpm and the system controller activated a low flow alarm.The system continued to operate at the set speed with 0 lpm flow until 1:45 when the driveline was disconnected.The periodic log file contained events recorded from (b)(6) 2021 when normal operation was recorded until july 6 when the calculated average flow decreased to 0 lpm and the system activated a low flow alarm.The returned system controller was functionally tested using the laboratory equipment and was found to function as intended.The system controller was operated while connected to a mock circulatory loop and there were no atypical alarms/events observed.The system controller was tested while connected to the returned modular cable and there were no alarms reproduced.In conclusion, the investigation did not identify a correlation between the low flow events captured in the log files and the returned device.Heartmate 3 patient handbook, under section ¿alarms and troubleshooting¿ explains all alarms and the proper actions to take if the alarms cannot be resolved.The patient handbook, also 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 and the records revealed the controller was manufactured in accordance with mfg and qa specifications.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: SYSTEM CONTROLLER, HM 3, LOW FLOW 2.0
• Common Device Name: HEARTMATE 3 CONTROLLER
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 12259100
• Report Number: 2916596-2021-04162
• Device Sequence Number: 11940383
• Product Code: DSQ
• UDI-Device Identifier: 05415067031105
• UDI-Public: 05415067031105
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P160054
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2021

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: 04/22/2023
• Device Model Number: 106531LF2
• Device Catalogue Number: 106531LF2
• Device Lot Number: 7485475
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/06/2021
• Supplement Date Received by Manufacturer: 10/13/2021
• Initial Report FDA Received Date: 08/02/2021
• Supplement Report FDA Received Date: 10/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 96