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

Device Problem Output Problem (3005)

Patient Problems Anemia (1706); Hemorrhage/Bleeding (1888)

Event Date 05/02/2021

Event Type  malfunction  

Event Description

Patient with heartware hvad was admitted due to recurrent symptomatic anemia/melena in the setting of inr 3.4 and hemoglobin 5.8 on coumadin (no aspirin therapy).Five units of blood were transfused over the course of the hospitalization.Endoscopic evaluation included an egd push and a capsule study which failed to identify the area of bleeding.A heparin to coumadin bridge was completed prior to discharge.

• Brand Name: HEARTWARE HVAD SYSTEM
• Type of Device: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): HEARTWARE, INC.; 500 old connecticut path; framingham MA 01701
• MDR Report Key: 12525353
• MDR Text Key: 273108967
• Report Number: 12525353
• 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: Nurse
• Type of Report: Initial
• Report Date: 09/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2021
• Is this an Adverse Event Report?: No
• 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: 09/09/2021
• Device Age: 3 YR
• Event Location: Home
• Date Report to Manufacturer: 09/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 22265 DA
• Patient Weight: 100