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

Model Number 106762

Device Problems No Display/Image (1183); Device Difficult to Setup or Prepare (1487); Communication or Transmission Problem (2896); Connection Problem (2900)

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

Event Date 08/20/2020

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

The patient's controller did not register when connected to the driveline.The controller was exchanged.No further information was reported.

Manufacturer Narrative

Section d4: multiple attempts were made to obtain additional information from the customer regarding the event (including device serial number); however, no additional information was provided.Manufacturer investigation conclusion: the reported event of the system controller being unable to communicate with the system monitor could not be confirmed as the system controller was not returned for analysis.Additional information provided stated that the issue happened with multiple system monitors.It was resolved by exchanging the system controller.Multiple attempts were made to obtain additional information from the customer regarding the event; however, no additional information was provided.The root cause of the reported event could not be conclusively determined through this analysis.Heartmate ii instructions for use section 4 ¿ ¿system monitor¿ explains how to use the system monitor with the system controller, and the actions to take when communication cannot be established.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.No further information was provided.The manufacturer is closing the file on this event.

Event Description

Related manufacturer report number: 2916596-2020-04271.It was reported that staff were unable to successfully connect the system controller to the system monitor and no information was displayed on screen when connected to multiple consoles.The patient's controller was exchanged due to the failure to register when connected.

• Brand Name: HEARTMATE II SYSTEM CONTROLLER
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 10521074
• MDR Text Key: 207193441
• Report Number: 2916596-2020-04559
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• PMA/PMN Number: P060040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 106762
• Device Catalogue Number: 106762
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS)
• Patient Age: 71 YR
• Patient Weight: 101