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

Model Number 106531US

Device Problem Premature Discharge of Battery (1057)

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

Event Date 08/05/2021

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 noted that the battery connected to the system controller's white power lead drained faster than the black power lead.Log file analysis confirmed that there was a possibility that the battery connected to the white power lead was draining faster than expected.The patient underwent a controller exchange on (b)(6) 2021 due to these issues.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of the white power cable draining faster than expected was not confirmed; however, it was confirmed via product testing that both power cables of the system controller had higher than expected resistances.The heartmate 3 (serial #: (b)(6) ) was returned for analysis, a log file was downloaded, and a log file was submitted for review.The submitted and downloaded log files contained overlapping events spanning approximately 6 days((b)(6) 2021 per timestamp).Events on (b)(6) 2021 are from product testing at abbott.Throughout the log file it is observed that the rsoc voltage on the white power cable was slightly lower while compared to the black power cable while on 14v battery power; however, no atypical low voltage events occurred and the 14v batteries were able to operate longer than the expected minimum of 6 hours as indicated in the heartmate 3 patient handbook.There were no atypical alarms.Pump operation was not affected.The heartmate 3 system controller was tested and passed preliminary testing.During functional testing the controller did not pass 4 stages due to higher-than-expected resistances on multiple wires of the power cables.The system controller was opened, and it was confirmed that every wire of both power cables had higher than expected resistance.Although not confirmed, higher resistances may contribute to faster than expected drain on the 14v batteries.The system controller was still able to operate on a mock loop despite the higher resistances.The root cause of the reported event was unable to be determined in this analysis.Incidental findings: damaged strain relief, fluid ingress the device history records were reviewed and the records revealed the heartmate iii system controller (serial#: (b)(6) ) was manufactured in accordance with manufacturing and qa specifications.Heartmate iii instructions for use section 7 ¿ ¿alarms and troubleshooting¿ and heartmate iii patient handbook section 5 ¿ ¿alarms and troubleshooting¿ explains how to properly interpret and troubleshoot all alarms, including low voltage alarms.Heartmate iii instructions for use section 3 ¿ ¿powering the system¿ and heartmate iii patient handbook section 3 ¿ ¿powering the system¿ addresses that fully charged 14v batteries can power the system for up to 6¿17 hours, depending on the patient's activity level.Heartmate iii instructions for use section 8 ¿ ¿equipment storage and care¿ and heartmate iii patient handbook section 6 ¿ ¿caring for equipment¿ explain how to properly care for the equipment.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: 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: 12435142
• MDR Text Key: 270321243
• Report Number: 2916596-2021-04911
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/29/2021

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/24/2021
• Device Model Number: 106531US
• Device Catalogue Number: 106531US
• Device Lot Number: 6466291
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/09/2021
• Initial Date FDA Received: 09/07/2021
• Supplement Dates Manufacturer Received: 11/17/2021
• Supplement Dates FDA Received: 11/29/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/25/2018
• 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: 42 YR
• Patient Sex: Male
• Patient Weight: 82 KG