MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LVAS IMPLANT KIT; VENTRICULAR (ASSISST) BYPASS

Model Number 106524US

Device Problems Malposition of Device (2616); Infusion or Flow Problem (2964)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/18/2020

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 patient was having intermittent low flow alarms.The flows were ranging from 2.2 - 2.6 lpm (liters per minute).It was reported that the patient had a small lvedd of 3.8.The inflow cannula was aimed slightly toward the septum.Clinicians were working on controlling blood pressure and optimizing volume status.It was reported that the patient was asymptomatic.It was reported that the patient had their controller's software upgraded to the low flow software on (b)(6) 2020.No further alarms were noted by the patient at that time.

Manufacturer Narrative

Manufacturer's investigation conclusion: the report of low flow alarms was confirmed through the esr submitted by an abbott representative.The account reported that the patient has had intermittent low flow alarms.The patient has small lvedd of 3.8.And inflow aimed slightly toward septum.Clinicians have been working on controlling blood pressure and optimizing volume status.The account requested a software upgrade on the patient¿s controllers with a low flow hazard alarm threshold set to 2.0lpm.According to the account, the updated software was successful on both primary and backup controllers.The patient remains ongoing on heartmate 3 lvas, serial number (b)(6), and no further issues have been reported.The heartmate 3 lvas ifu explains that the low flow hazard alarm will be triggered when pump flow is less than 2.5 lpm and notes that changes in patient conditions can result in low flow.This ifu, as well as the patient handbook, describes all system alarms and the recommended actions associated with them.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE 3 LVAS IMPLANT KIT
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 10245543
• MDR Text Key: 198329674
• Report Number: 2916596-2020-03421
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013297
• UDI-Public: 00813024013297
• Combination Product (y/n): N
• PMA/PMN Number: P160054
• 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: 09/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/05/2022
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 7316903
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Weight: 80