MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, NA; VENTRICULAR (ASSISST) BYPASS

Model Number 106015

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Right Ventricular Dysfunction (2054)

Event Date 10/22/2019

Event Type  Injury  

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 patient experienced multiple low flow alarms.It was found by echo that the patient was hypervolemic with a stable but reduced right ventricle function and moderate to severe valvular disease.She was instructed to increase torsemide to 20 mg for the next 2 days and then resume torsemide 20 mg daily.She will be reassessed in clinic in one week.She was discharged home with the above instructions.No further information provided.

Manufacturer Narrative

Manufacturer's investigation conclusion: analysis of the log file provided by the account confirmed low flow alarms; however, a specific cause for this finding could not be conclusively determined through this evaluation.In addition, a direct correlation between heartmate ii lvas, serial number (b)(6) and the reported event could not be conclusively determined.The submitted log file contained data from (b)(6) 2019 through (b)(6) 2019.The log file captured a constant low flow hazard alarm throughout the duration of the file (211 total low flow hazard alarms).The estimated flow was below 2.5 lpm (was 2.4 lpm) during these events.Despite the observed events, the system appeared to be operating as intended and the pump speed remained above the low speed limit for the duration of the log file.The patient remains ongoing on heartmate ii lvas, serial number (b)(6) with no further reported issues.The hmii lvas ifu lists right heart failure as an adverse event that may be associated with the use of the heartmate ii left ventricular assist system.Both the ifu and patient handbook addresses all system controller alarms (including low flow hazard alarms) and how to respond to such events.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, NA
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 95488
• MDR Report Key: 9298576
• MDR Text Key: 165997179
• Report Number: 2916596-2019-05128
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024011224
• UDI-Public: 00813024011224
• Combination Product (y/n): N
• PMA/PMN Number: P060040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 11/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2019
• Device Model Number: 106015
• Device Catalogue Number: 106015
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/25/2019
• Initial Date FDA Received: 11/08/2019
• Supplement Dates Manufacturer Received: 11/20/2019
• Supplement Dates FDA Received: 11/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 32 YR
• Patient Weight: 88