MAUDE Adverse Event Report: HeartWare, Inc. HeartWare Ventricular Assist System - Pump; VENTRICULAR (ASSISST) BYPASS

Model Number	1103
Medical Device Problem Codes	Increase in Suction (1604); Pumping Problem (3016)
Health Effect - Clinical Codes	Anemia (1706); Fatigue (1849); Hypovolemia (2243); Kidney injury (4882)
Date of Event	09/11/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The ventricular assist device (vad) patient was admitted to the hospital with fatigue, acute kidney injury (aki), anemia, and hypovolemia.A review of the log-file data revealed motor-start events with parameters outside the typical range.The log-file review also showed low-flow alarms and suction events with worsening trends.Additional review identified unexpected power-loss events.The patient has a history of motor-start events associated with accidental double power disconnects.The patient reported that they may have accidentally disconnected the device again but were unsure.Based on the available log-file data and the patient's history, the vad team suspects that an accidental power disconnection is the most likely explanation for the unexpected power-loss and motor-start events.The patient was treated with volume resuscitation.The vad remains in use, and no further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Investigation of this event is pending and a supplemental report will be sent upon its completion.Additional products: d1: heartware ventricular assist system controller d4: model #: 1420 / catalog #: 1420 / expiration date: 31-jan-2019/ serial #: (b)(6) d9: no h3: no h4: mfg date: 15-jan-2018 h5: no h6: the codes present in section h6 correspond to components/products that comprise the reported event.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: HeartWare Ventricular Assist System - Pump
• Common Device Name: 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: gerard torenvliet ; 8200 coral sea st ne; mounds view, MN 55112--439 ; +1(763)526-9277
• MDR Report Key: 50870859
• Report Number: 3007042319-2026-01453
• Device Sequence Number: 9379774
• Product Code: DSQ
• UDI-Device Identifier: 00888707000017
• UDI-Public: (01)00888707000017(17)180831
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P100047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/31/2018
• Device Model Number: 1103
• Device Catalogue Number: 1103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/31/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 800SR30 HEART RING, 690R28 HEART RING
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 137 LB