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

Model Number 106524US

Device Problems Infusion or Flow Problem (2964); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Diarrhea (1811); Dizziness (2194); Hypovolemia (2243); Epistaxis (4458); Gastrointestinal Hemorrhage (4476)

Event Date 06/06/2022

Event Type  Injury  

Event Description

It was reported that the patient presented to the emergency room (er) on (b)(6) 2022 with a nosebleed and bloody diarrhea.The patient had 1 low flow alarm but denied any dizziness or lightheadedness.They denied having any nausea or vomiting.The patient's hemoglobin level was 9.2.Their international normalized ratio (inr) was 1.5.A review of the log files revealed audible low flow events on (b)(6) 2022 at 1801.At other times, on (b)(6) 2022 at 1723,1736, and 2001, the calculated flow was at the 2.5 lpm threshold but was not sustained long enough to trigger the audible alarm.The patient did experience lightheadedness during the low flow alarm.The nosebleed resolved after treating with rhino rocket nasal packing.The cause of the low flow alarms was suspected to be hypovolemia, which resolved with volume resuscitation.

Manufacturer Narrative

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

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct correlation between (b)(6) and the reported bleeding, gastrointestinal bleeding, and low flow events could not be conclusively determined through this investigation.Review of the submitted log files confirmed low flow events.According to the account, the low flow events were caused by hypovolemia.The controller event log file captured nine low flow fault flags resulting in one low flow hazard alarm on 06jun2022 at 18:01:47.The account reported that the cause for these events was likely hypovolemia.No other atypical events were captured.Despite these events, the pump appeared to function as intended and operated at the set speed for the duration of the file.The patient remains ongoing on heartmate 3 left ventricular assist system (lvas), serial number (b)(6).No product is available for investigation.The heartmate 3 lvas ifu, rev.C, lists bleeding as an adverse event that may be associated with the use of the heartmate 3 left ventricular assist system.The patient care and management section provides information regarding anticoagulation, including the recommended inr values.The system monitor section of the ifu describes the pump flow display and pulsatility index (4-12 through 4-16) and the hazard alarms (4-18 and 4-30).This document states that the low flow hazard alarm will be triggered when pump flow is less than 2.5lpm and explains that changes in patient conditions can result in low flow.The alarms and troubleshooting section describes the actions to take in the event of a low flow alarm (7-7 and 7-11).The heartmate 3 lvas patient handbook, rev.D, is also currently available.Section 5 of this handbook, entitled "alarms and troubleshooting," describes the actions to take in the event of a low flow alarm.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The pump shipped on 11sep2021.

• Brand Name: HEARTMATE 3 LVAS IMPLANT KIT
• 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: 14788247
• MDR Text Key: 294880609
• Report Number: 2916596-2022-11726
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013297
• UDI-Public: 00813024013297
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date: 06/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/25/2023
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 8015339
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2021
• 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 Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 58 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White