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

Model Number 106524US

Device Problem Infusion or Flow Problem (2964)

Patient Problem Right Ventricular Dysfunction (2054)

Event Date 02/19/2020

Event Type  Injury  

Manufacturer Narrative

No additional 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 readmitted on (b)(6) 2020 due to low flow alarms.Upon interrogation, the vc found there were approximately 13-14 alerts with low flow alarms.They started the patient on sildenafil due to moderate right ventricular dysfunction.The patient was discharged on (b)(6) 2020.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported low flow alarms could not be conclusively determined through this investigation as no log files from the time of the reported event were provided by the account.The patient was readmitted to the center on (b)(6) 2020 due to low flow alarms.The vad coordinator reported 13-14 low flow events with alarms upon device interrogation.The patient was started on sildenafil due to moderate right ventricular dysfunction and remains ongoing on heartmate 3 lvas, serial number, (b)(6).No further low flow alarms were reported until cs-137196.The heartmate 3 lvas ifu explains that the low flow hazard alarm will be triggered when pump flow is less than 2.5lpm and notes that changes in patient conditions can result in low flow.The ifu describes all system alarms and the recommended actions associated with them.No additional information was reported.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: 10082167
• MDR Text Key: 191800196
• Report Number: 2916596-2020-02556
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 08/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/21/2022
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 7149464
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Weight: 76