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

Model Number 1420

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 06/06/2022

Event Type  malfunction  

Manufacturer Narrative

Investigation of this event is pending and a supplemental report will be sent upon its completion.Additional products: heartware ventricular assist system ¿ shoulder pack model #: unk / catalog #: unk / expiration date: unk / lot#: unknown udi #: asku device evaluated: no.No, device evaluation anticipated, but not yet begun; mfg date: unk; labeled for single use: no.Additional information has been requested regarding the serial numbers and event details of the event, but it was not available at the time of this report.If additional information is received, the event will be updated and a supplemental report will be sent.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the controller exhibited an unknown alarm and undefined bleep tone when closing the zippers of their shoulder pack.Of note, the site associated the observation to patient behavior or environment related.The controller and shoulder pack 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: one (1) controller and one (1) shoulder pack were not returned for evaluation.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 data log file revealed multiple momentary disconnections within the analyzed period.Momentary disconnections will result in an audible tone or ¿beep¿.Review of the alarm log file did not reveal any alarms within the analyzed period, however, it is likely that the momentary disconnections were perceived by the patient as the reported ¿unknown alarms¿.As a result, the reported event was confirmed.The associated batteries had been lubricated prior to release.Of note, it was reported that the ¿beeps¿ were induced by the patient manipulating the power source cables when opening and closing the zippers of the shoulder pack.The most likely root cause of the observed momentary disconnections can be attributed, but not limited, to a temporary corrosion of the controller-port/power-source pins and/or the user manipulating the power source cables leading to an intermittent connection.Additional products: d4: serial or lot#: unknown - shoulder pack h6: fda method code(s): b17 h6: fda results code(s): c20 h6: fda conclusion code(s): d14 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 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.

Manufacturer Narrative

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 further reported that the beeps were induced by patient manipulation of the power source cables when opening and closing the zippers of the shoulder pack.

• Brand Name: HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): HEARTWARE INC.; 14400 nw 60th avenue; miami lakes FL 33014
• Manufacturer (Section G): HEARTWARE INC.; 14400 nw 60th avenue; miami lakes FL 33014
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 14775751
• MDR Text Key: 301372021
• Report Number: 3007042319-2022-05478
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P100047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2021
• Device Model Number: 1420
• Device Catalogue Number: 1420
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2020
• 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
• Treatment: 1104 VAD
• Patient Age: 69 YR
• Patient Sex: Female