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

Model Number MCS1705PU

Device Problems Battery Problem (2885); Power Problem (3010); Pumping Problem (3016)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/17/2024

Event Type  malfunction  

Manufacturer Narrative

Additional product: d1: heartware ventricular assist system ¿controller 2.0 d4: model #:  1420/ catalog #:1420/ expiration date: 31-dec-2021/ serial or lot#: (b)(6) udi #: (b)(4) d9: no h3: no h4: mfg date:  01-dec-2020 h5: no d1: heartware ventricular assist system ¿ battery d4: model #: 1650/ catalog #: 1650 / expiration date: 31-may-2024 serial or lot#: (b)(6) udi #: (b)(6) d9: no h3: no h4: mfg date:  18-may-2023 h5: no d1: heartware ventricular assist system ¿ battery d4: model #: 1650/ catalog #: 1650 / expiration date: 30-sep-2024 serial or lot#: (b)(6) udi #: (b)(4) d9: no h3: no h4: mfg date:  08-sep-2023 h5: no investigation of this event is pending and a supplemental report will be sent upon its completion.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.

Event Description

It was reported that the ventricular assist device (vad) exhibited multiple motor start events with parameters outside of the typical range.Additionally, the controller exhibited a loss of power and two batteries exhibited power switching.  the ventricular assist device (vad) and the controller remain in use.The batteries were exchanged.No patient complications have been reported as a result of this event.

• 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: 19004250
• MDR Text Key: 338912735
• Report Number: 3007042319-2024-01385
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00888707005364
• UDI-Public: 00888707005364
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2022
• Device Model Number: MCS1705PU
• Device Catalogue Number: MCS1705PU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/28/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Sex: Male