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

Model Number 1650DE

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

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

Event Date 02/25/2024

Event Type  malfunction  

Manufacturer Narrative

Additional product: d1: heartware ventricular assist system ¿pump d4: model#:  1104 / catalog#:1104 / expiration date: 31-jul-2022 / serial#: (b)(6) udi#: (b)(4) h3: no d9: no h4: mfg date:  28-jul-2020 h5: no h6: the codes present in section h6 correspond to components/products that comprise the reported event.Investigation of this event is pending and a supplemental report will be sent upon its completion.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the battery exhibited power disconnect alarms, and the ventricular assist device (vad) exhibited low flows alarms.The vad and the battery remain in use.No patient complications have been reported as a result of this event.

Manufacturer Narrative

A supplemental report is being submitted for device evaluation.Product event summary: the ventricular assist device (vad) (b)(6) and battery (b)(6) were not returned for evaluation.Log file analysis revealed 101 low flow alarms logged since (b)(6) 2024.Log file analysis revealed that the controller in use during the reported event (b)(6)contained a feature that records whether a power source experienced a communication error or a disconnection within each 15-minute interval.Analysis of the log files did not reveal any power disconnect alarms within the analyzed period.However, review of the data log file revealed an instance involving (b)(6) where the battery¿s relative state of charge (rsoc) was between 101-201, which is indicative of a communication error.A communication error will trigger a power disconnect alarm if the other power source is a battery with an rsoc greater than 25%.As a result, the reported events was confirmed.(b)(6) was lubricated prior to release.Possible root causes of the communication errors, and resulting power disconnect alarms, can be attributed to momentary disconnections on the communication pins of the controller, the controller not receiving responses from the batteries, and/or due to the packet error checking method detecting bit errors.Based on the available information, the device may have caused or contributed to the reported low flow event.Based on the risk documentation, possible causes of the reported low flow event may be attributed to multiple factors including but not limited to thrombus at the inflow cannula/outflow graft, constriction at the outflow graft, poor vad filling, and/or inappropriate pump rotational speed.Investigation of this event is completed and the file will be closed.If new information is received, the file will be re-opened and a supplemental will be submitted.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 - BATTERY
• 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: 18818015
• MDR Text Key: 336778300
• Report Number: 3007042319-2024-01148
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00763000629717
• UDI-Public: 00763000629717
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P100047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2024
• Device Model Number: 1650DE
• Device Catalogue Number: 1650DE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/27/2024
• Initial Date FDA Received: 03/01/2024
• Supplement Dates Manufacturer Received: 05/03/2024
• Supplement Dates FDA Received: 05/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/25/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1