MAUDE Adverse Event Report: HEARTWARE INC. HVAD PUMP IMPLANT KIT; VENTRICULAR (ASSIST) BYPASS

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problems Fatigue (1849); Low Blood Pressure/ Hypotension (1914); Nausea (1970)

Event Date 09/11/2021

Event Type  Injury  

Event Description

Patient presented to ed after consultation with lvad coordinator due to low flows.He was alert and oriented on my assessment.Pale, fatigued and nauseated.Intermittently pulsatile.Non-invasive blood pressure mean arterial pressure 84.Wife at bedside.Lvad actively alarming low flow.Connected to monitor.Flow shows abrupt drop in last 12-16 hours, now 0.3.Power now 2.9.Wife states low flows have been present since last pm, did not improve with fluids.She did not look at flow value last pm.Patient with history of suspected inlet thrombus in 9 months ago.Last in clinic two weeks ago, at that time power (w): 4.7 4.9 / 3.6 - 5.5.Of note, controller time and date 8 months ago.Unclear why.Wife states no controller exchange.Updated time/date to correct.Sent urgent logfile analysis to medtronic.See analysis below.Providers suspect recurrence of inlet thrombus.Manufacturer response for lvad, (brand not provided) (per site reporter).Unknown, analysis sent to manufacturer.

• Brand Name: HVAD PUMP IMPLANT KIT
• Type of Device: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): HEARTWARE INC.; 14400 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 12561446
• MDR Text Key: 274299169
• Report Number: 12561446
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/15/2021
• Event Location: Hospital
• Date Report to Manufacturer: 10/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 28835 DA
• Patient Weight: 81