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

Model Number 103696

Event Date 07/13/2022

Event Type  malfunction  

Event Description

It was reported that the patient heard a continuous sound when they were connecting to the power module.The patient claimed to have a low flow alarm but when the medical engineer checked the history on the system monitor, there was no record of the alarm.There was concern for driveline fatigue.A review of the log files revealed a pump stop on 29jun2022 and the clock reset.This was due to a double power cable disconnect while doing a power source change over from the batteries to the power module.

Manufacturer Narrative

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

Manufacturer Narrative

No further information was provided.The manufacturer is closing the file on this event.

Manufacturer Narrative

Section d6a: implant date inadvertently included in previous report.Implant date is not applicable for heartmate ii system controller.Manufacturer's investigation conclusion: the reported event of a pump stop followed by a clock reset was confirmed via the submitted log file.A review of the submitted log file spanned approximately 19 days (day 1857 hour 13 minute 8 ¿ day 1859 hour 4 minute 55 and day 0 hour 0 minute 0 ¿ day 15 hour 15 minute 53 per time stamp).On day 1859 hour 4 minute 55 while connected to batteries, the no external power alarm activated due to both power cables being disconnected simultaneously during a power source exchange.This resulted in a pump stop and clock reset.No other notable alarms were active in the log file.System controller, serial number epc-44048, was not returned for analysis and remains in use.A root cause for the reported event was due to user error by disconnecting both power cables simultaneously.Device history records were reviewed and showed no deviations from manufacturing or quality assurance specifications.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.Heartmate ii instructions for use section 7-¿alarms and troubleshooting¿ and heartmate ii patient handbook section 5-¿alarms and troubleshooting¿ explain how to properly interpret and troubleshoot no external power alarms.Heartmate ii instructions for use section 2 - ¿system operations¿ and heartmate ii patient handbook section 2 - ¿how your heart pump works¿ warns the user that at least one system controller power cable must be connected to a power source at all times.No further information was provided.The manufacturer is closing the file on this event.

Event Description

Related manufacturer report number: 2916596-2022-12365.

• Brand Name: HEARTMATE II SYSTEM CONTROLLER, US, EP
• 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: 15057605
• MDR Text Key: 303854425
• Report Number: 2916596-2022-12355
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024010630
• UDI-Public: 00813024010630
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P060040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/16/2022

1 Device 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: 01/31/2020
• Device Model Number: 103696
• Device Catalogue Number: 103696
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/13/2022
• Initial Date FDA Received: 07/19/2022
• Supplement Dates Manufacturer Received: 07/26/2022; 08/16/2022
• Supplement Dates FDA Received: 08/08/2022; 08/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial