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

Model Number 106524INT

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/13/2020

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 device was having low flow alarms and the physician requested a 2.0 lpm software change in the system controllers.It was determined that the cannula position did not allow for more revolutions per minute (rpm) since the device presented with multiple low flow alarms.Drug changes, lowering hematocrit value in the interrogator, hydration, and a ramp test with right heart catheterization were not successful in decreasing the alarm episodes.

Manufacturer Narrative

Manufacturer's investigation conclusion: the report of low flow alarms could not be confirmed, as no log files or equipment service report were submitted for evaluation.Inflow canula misalignment was confirmed via the submitted x-ray.A direct correlation between the heartmate 3 left ventricular assist system (lvas), serial number (b)(6), and the malposition of the inflow cannula could not conclusively be established through this evaluation.The patient remains ongoing on heartmate 3 support.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The heartmate 3 lvas instructions for use (ifu) explains how to insert the pump in the ventricle and instructs the user to take care to avoid orienting the inlet towards the interventricular septum.This document also outlines the steps to reorient the pump.In addition, this ifu explains that the low flow hazard alarm is triggered when pump flow is less than 2.5 liters per minute (lpm).This ifu and the patient handbook explain all system alarms and the recommended actions associated with them.No further information was provided.The manufacturer is closing the file on this event.

Event Description

It was reported that after the 2.0 low flow software update, the number of low flow alarms decreased dramatically.No additional information was provided.

Manufacturer Narrative

Updated manufacturer's investigation conclusion: the report of low flow alarms was confirmed by an on-site abbott technical services representative.Inflow canula misalignment was confirmed via the submitted x-ray.A direct correlation between the heartmate 3 left ventricular assist system (lvas), serial number (b)(6), and the malposition of the inflow cannula could not conclusively be established through this evaluation.The patient reportedly has multiple low flow alarms despite optimal medical treatment.The canula position does not allow for increased rpm of the pump.A low flow software upgrade was requested on 06sep2020.Software version 1.5.2 was successfully installed on the patient¿s system controller, serial number (b)(6) on (b)(6) 2020 without issue.No further alarms were reported following the upgrade.The patient remains ongoing on heartmate 3 support.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The heartmate 3 lvas instructions for use (ifu) explains how to insert the pump in the ventricle and instructs the user to take care to avoid orienting the inlet towards the interventricular septum.This document also outlines the steps to reorient the pump.In addition, this ifu explains that the low flow hazard alarm is triggered when pump flow is less than 2.5 liters per minute (lpm).This ifu and the patient handbook explain all system alarms and the recommended actions associated with them.No further information was provided.The manufacturer is closing the file on this event.

Event Description

Low flow alarms were confirmed by an on-site abbott technical services representative.

• 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: 10696105
• MDR Text Key: 211858154
• Report Number: 2916596-2020-05162
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 813024011712
• UDI-Public: (01)813024011712
• 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,Followup
• Report Date: 12/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/14/2022
• Device Model Number: 106524INT
• Device Lot Number: 7290738
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention