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

Model Number 106531US

Device Problems Misconnection (1399); Device Difficult to Setup or Prepare (1487)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/14/2020

Event Type  malfunction  

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

It was reported that the patient was connected to (b)(4).The bend relief in white cable was completed broken through all layers, no damage was noted in underlying cable and no alarms were noted.It was attempted twice to switch to the patient's back-up controller ((b)(4)).Both attempts were unsuccessful due to the driveline being unable to click into the pocket controller.The driveline of the patient would not seat into the opening.The controller and connections were inspected and no damage was noted.This is the first time patient was hooked up to this controller since implant.Attempted a second connect with vad coordinator and vad cardiologist, that was unsuccessful.Reconnected to original controller to recover patient.The final connection was made to brand new controller without difficulty as primary controller (b)(4).During disconnect patient became symptomatic and felt dizzy, lightheaded, and noticeable less alert.Elected to reconnect patient to the damaged cable controller to re-establish flow.Patient recovered in matter of seconds.The patient did not have any additional symptoms.There were no alarms after the controller was exchanged.The patient was now stable at home.(b)(4).

Manufacturer Narrative

(b)(6) is addressed under mfr#: 2916596-2020-06329.Modular cable is addressed under mfr#: 2916596-2020-06328.Manufacturer's investigation conclusion: incidental findings: backup battery fault.The controller was connected to a test power module/system monitor and a log file, (b)(4), was downloaded to determine the specific fault associated with the backup battery fault alarm.Review of the log file revealed that the alarm was due to a backup battery circuit fault (error code f34).The battery was visually inspected and was in unremarkable condition.The outer casing of the backup battery was removed to inspect the battery¿s internal components, and no issues were observed.Circuit analysis performed on the battery revealed that the output of pin 2, associated with the const_lcs_pwr signal, was measured to be 0v when it should be measuring approximately 12.3 volts.Further evaluation revealed that fuse f2 was open, which resulted in the loss of output on pin 2.A wire was soldered onto to backup battery to make the connection between the two terminals of f2.The resistance was then measured to be 0.2 ohms.The battery was then reconnected to the system controller, system monitor, and pump and the backup battery operated as intended with no alarms.The controller was disconnected from external power and the backup battery supported the pump without issue.The backup battery fault was determined to be caused by fuse f2 being open; however, the root cause of the fuse being open could not be conclusively determined through this analysis.The reported event of difficulty inserting the driveline into the system controller was confirmed evaluation of the returned controller (serial number: (b)(6).The heartmate 3 system controller, serial number: (b)(6), was returned for analysis and functionally tested and passed; however, it was noted that extra force was required when inserting the driveline into the bulkhead assembly.Further evaluation of the bulkhead assemble revealed that the atypical resistance was due to excess debris inside the bulkhead assembly where the driveline enters.Once the debris was cleared, no additional resistance was noticed.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.(b)(6) was shipped to the customer on (b)(6) 2018.The heartmate 3 patient handbook under section 2 ¿how your heart pump works,¿ under sub-section titled "connecting the driveline to the system controller,") addresses the proper steps for connecting the driveline to the system controller.Heartmate 3 patient handbook under section 5 ¿alarms and troubleshooting¿ and heartmate iii instructions for use (ifu) under section 7 ¿alarms and troubleshooting¿, cover all alarms (visual and audible), including the backup battery fault alarm conditions, and the actions to take if the alarms cannot be resolved.The heartmate 3 patient handbook and heartmate iii instructions for use (ifu) 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.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of difficulty inserting the driveline into the system controller was confirmed evaluation of the returned controller (serial number (b)(6) ).The heartmate 3 system controller, serial number (b)(6) , was returned for analysis and functionally tested and passed; however, it was noted that extra force was required when inserting the driveline into the bulkhead assembly.Further evaluation of the bulkhead assemble revealed that the atypical resistance was due to excess debris inside the bulkhead assembly where the driveline enters.Once the debris was cleared, no additional resistance was noticed.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.(b)(6) was shipped to the customer on 26feb2018 in ifs order # (b)(4).The heartmate 3 patient handbook under section 2 ¿how your heart pump works,¿ under sub-section titled "connecting the driveline to the system controller,") addresses the proper steps for connecting the driveline to the system controller.Heartmate 3 patient handbook under section 5 ¿alarms and troubleshooting¿ and heartmate iii instructions for use (ifu) under section 7 ¿alarms and troubleshooting¿, cover all alarms (visual and audible), including the backup battery fault alarm conditions, and the actions to take if the alarms cannot be resolved.The heartmate 3 patient handbook and heartmate iii instructions for use (ifu) 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
• MDR Report Key: 11097780
• MDR Text Key: 224788680
• Report Number: 2916596-2020-06325
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013235
• UDI-Public: 00813024013235
• Combination Product (y/n): N
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/23/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2020
• Device Model Number: 106531US
• Device Catalogue Number: 106531US
• Device Lot Number: 6334497
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/14/2020
• Initial Date FDA Received: 12/30/2020
• Supplement Dates Manufacturer Received: 03/02/2021; 03/02/2021
• Supplement Dates FDA Received: 03/19/2021; 03/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HEARTMATE 3 SYSTEM CONTROLLER, SN: (B)(6) ; HEARTMATE 3 VAD MODULAR CABLE, BATCH/LOT #199192
• Patient Age: 63 YR
• Patient Weight: 104