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

Model Number 1286INT

Device Problems Display or Visual Feedback Problem (1184); Output Problem (3005)

Patient Problem No Patient Involvement (2645)

Event Date 05/21/2020

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 hospital received back the system monitor from service.When connected to the power module and system controller, the user was unable to change from screens or activate any menu option.The power module, patient cable and -vsm>ppm (system monitor to power module) connecting cable were exchanged.A different system controller was connected as well.These changes all yielded the same result - there was no response to touch commands.Software 7.32 was re-installed and the system monitor was removed from use.

Manufacturer Narrative

Section d10, h3, h4: additional information section h5 and h8: correction manufacturer's investigation conclusion: the reported event of not being able to change things on the system monitor touchscreen was confirmed.Vsm-006611 was evaluated on 24jun20.The reported event was verified.The main board was replaced resolving the issue.The system monitor underwent functional checkout before being returned to the customer site.The main board was evaluated and found that the internal flash memory was not functioning as intended.The internal flash memory was replaced with a test internal flash memory which resolved the issue.A root cause of the reported event was determined to be an issue with the internal flash memory; however, the root cause of an issue with the internal flash memory was not determined through this analysis.Device history records were reviewed and showed no deviations from manufacturing or qa specifications.Vsm-006611 was shipped to the customer on 7nov2018.Heartmate ii instructions for use section 4-¿system monitor¿ and heartmate ii patient handbook section 6-¿caring for the equipment¿ explain how to properly handle the monitor to prevent damage.Heartmate system monitor instructions for use (ifu) informs the user to refer any servicing of heartmate lvas equipment to trained service personnel only.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE SYSTEM MONITOR
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 10137361
• MDR Text Key: 194609110
• Report Number: 2916596-2020-02764
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 09/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1286INT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1