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

Model Number 1103

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Renal Failure (2041); Sepsis (2067); Septic Shock (2068)

Event Date 06/23/2022

Event Type  Death  

Manufacturer Narrative

Investigation of this event is pending and a supplemental report will be sent upon its completion. If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the ventricular assist device (vad) patient was admitted from a skilled nursing facility (snf) in acute renal failure with digoxin toxicity, fecal impaction with gastrointestinal bleeding, and shock related to sepsis. Despite appropriate therapeutic measures, including fecal disimpaction, antibiotic therapies, continuous renal replacement therapy (crrt), and pressor support, the patient continued to decline. The patient was transitioned to comfort measures and passed away peacefully.

• 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
• Manufacturer (Section G): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 15117576
• Report Number: 3007042319-2022-06742
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00888707000017
• UDI-Public: 00888707000017
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 09/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 04/30/2017
• Device Model Number: 1103
• Device Catalogue Number: 1103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/29/2022
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Age: 83 YR
• Patient Sex: Female
• Patient Weight: KG
• Patient Outcome(s): Death