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

Model Number 106762

Device Problem Alarm Not Visible (1022)

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

Event Date 05/30/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the patient had low flow alarms that were not audible to them at home.Pump mfr # 2916596-2023-03875.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of the system controller¿s low flow and driveline fault alarms being inaudible was not confirmed.The system controller (serial number unknown) was not returned for analysis.The provided log file was reviewed, containing data spanning approximately 17 days (13may2023 ¿ 30may2023 per timestamp).The patient¿s flow was observed to be fluctuating throughout the data and briefly falling below the low flow threshold.The flow values did not remain below the alarm threshold for long enough to trigger an audible alarm.The observed driveline faults would also not have triggered an audible alarm due to the controller¿s software being version 7.29 and the fault information being pushed to the system monitor.These observed low flow flags and driveline faults have been addressed via the pumps investigation.Per additional information, no further information regarding the event was able to be provided.The root cause of the reported event was unable to be conclusively determined through this analysis.The serial number of the system controller was not provided.The heartmate ii patient handbook (section 10 ¿safety checklists¿) instructs users to regularly inspect their equipment for damage, including damage to the system controller¿s speakers, and to obtain replacements if needed.The heartmate ii patient handbook (section titled ¿emergency contact list¿) cautions 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 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: 17773595
• MDR Text Key: 323728039
• Report Number: 2916596-2023-06483
• Device Sequence Number: 1
• Product Code: DSQ
• 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: 09/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 106762
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 61 YR
• Patient Sex: Female
• Patient Weight: 106 KG