MAUDE Adverse Event Report: HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM-PUMP; VENTRICULAR (ASSISST) BYPASS

Model Number 1103

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fatigue (1849); Dizziness (2194); Blood Loss (2597)

Event Date 06/22/2018

Event Type  Injury  

Manufacturer Narrative

This device is used for treatment not diagnosis.The ventricular assist system is indicated for use as a bridge to cardiac transplantation and destination therapy in patients who are at risk of death from refractory end-stage left ventricular heart failure.The system is designed for in-hospital and out-of-hospital settings.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient presented to the clinic with complaints of low energy and feeling dizzy.Patient found to have a low hematocrit (hct).Patient was admitted to the hospital for a suspected gastrointestinal bleed (gib) and found to have a bleed in the small bowel requiring clip and cautery.The patient also had a subtherapeutic international normalized ratio (inr) and is tolerating a heparin infusion.The ventricular assist device (vad) remains in use.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

The pump was not returned for evaluation.The purpose of this investigation is to evaluate the device conformance to internal release requirements and/or to identify anomalies potentially introduced during use that may have prevented the pump from performing as intended.Log file analysis revealed 6 suction alarms have been recorded since (b)(6) 2018.There is no evidence to suggest that a device malfunction caused or contributed to the reported event.Based on the risk documentation, possible causes of the suction alarms may be attributed to multiple factors including, but not limited to, thrombus at the inflow cannula, poor vad filling, inappropriate pump rotational speed.Possible clinical factors that may have contributed to this event include the patient¿s pre-existing history and related comorbidities, the progression of their underlying disease, issues related to the therapeutic use of anticoagulant and antiplatelet medications and the patient's complex post-operative course.There are possible patient, pharmacological and procedural factors that may have contributed to this event.If information is provided in the future, a supplemental report will be issued.

• Brand Name: HEARTWARE VENTRICULAR ASSIST SYSTEM-PUMP
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 7723907
• MDR Text Key: 115156267
• Report Number: 3007042319-2018-03287
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00888707002639
• UDI-Public: 00888707002639
• Combination Product (y/n): N
• PMA/PMN Number: P100047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 11/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2020
• Device Model Number: 1103
• Device Catalogue Number: 1103
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 61 YR