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

Model Number 106762

Device Problems Display Difficult to Read (1181); Display or Visual Feedback Problem (1184); Electrical /Electronic Property Problem (1198); Data Problem (3196)

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

Event Date 04/11/2022

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

Related manufacturer reference number: 2916596-2022-10401.It was reported that the patient, while in inpatient rehab, had a controller fault alarm and was unable to access pump parameters via the 'display' button.Emergencies services were called and the patient was transferred to the emergency room.Upon inspection, the controller had a dim pump led.The controller was unable to be interrogated via the system monitor.The patient has a history of phase to phase shorts in the driveline due to driveline damage, so the decision was made to hold off on exchanging the controller until the cardiovascular surgical team was available.Plans were made to exchange the controller on (b)(6) 2022.The surgical team later decided against a controller exchange and made plans to exchange the pump on (b)(6) 2022.The patient's pump speed was 5400 rpm, international normalized ratio (inr) 2.0.The patient was stable with no symptoms.

Manufacturer Narrative

Section d6a: implant date was inadvertently included in the initial report but is not applicable for this device.Main investigation conclusion: the reported events of controller fault alarms and communication issues were unable to be confirmed; however, the event of a dim led was able to be confirmed.The heartmate ii system controller (serial number: (b)(6)) was returned for analysis, and a log file was downloaded for review.A review of the submitted log files showed events spanning approximately 4 days ((b)(6) 2022 per timestamp).There were no other notable alarms active in the log file.The system controller underwent preliminary and functional testing and passed.The controller was able to operate a mock loop without any alarms active.The controller was able to communicate with the system monitor and display the pump parameters.The controller functioned as intended.The root cause of the reported events were unable to be conclusively determined through this investigation.Incidental findings: fluid ingress, wire fatigue.Heartmate ii instructions for use, rev.C, section 2 entitled ¿system operations¿ and heartmate ii patient handbook, rev.C, section 5 entitled ¿alarms and troubleshooting¿ addresses how to properly interpret and troubleshoot all system alarms including controller fault alarm conditions, and the actions to take if the alarms cannot be resolved.Heartmate ii instructions for use, rev.C, section 8 entitled ¿equipment storage and care¿ and heartmate ii patient handbook, rev.C, section 6 entitled ¿caring for the equipment¿ addresses how to properly care for, maintain, and store the equipment for proper use.Heartmate ii instructions for use, rev.C, section 8 entitled ¿equipment storage and care¿ and heartmate ii patient handbook, rev.C, section 6 entitled ¿caring for the equipment¿ addresses how to properly care for and maintain the equipment for proper use including how to ensure that the controllers and equipment do not get wet.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 the device history records were reviewed for the system controller (serial number: (b)(6) ) and was found to pass all manufacturing and qa specifications before being shipped to the customer on 13oct2014.No further information was provided.The manufacturer is closing the file on this event.

Event Description

Related manufacturer report number: 2916596-2022-10401.

• Brand Name: HEARTMATE II SYSTEM CONTROLLER
• Type of Device: VENTRICULAR (ASSIST) 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: 14220224
• MDR Text Key: 290280844
• Report Number: 2916596-2022-10449
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024011286
• UDI-Public: 00813024011286
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P060040
• 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: 05/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2017
• Device Model Number: 106762
• Device Catalogue Number: 106762
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2014
• 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: 41 YR
• Patient Sex: Female
• Patient Weight: 129 KG