MAUDE Adverse Event Report: HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0; VENTRICULAR (ASSISST) BYPASS

Model Number 1420

Device Problems Battery Problem (2885); Incomplete or Inadequate Connection (4037)

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

Event Date 08/19/2021

Event Type  malfunction  

Event Description

It was reported that the controller and batteries exhibited multiple beeping and alarms.The controller remains in use and the batteries were exchanged.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Investigation of this event is pending and a supplemental report will be sent upon its completion.Concomitant medical products: ddmb1d4 icd, 457453; 6947m62 leads implanted on (b)(6) 2018.Additional products: heartware ventricular assist system - battery model #: 1650 / catalog #: 1650 / expiration date: 30-ap-2022/ serial or lot#: (b)(4) udi #: (b)(4).Device available for evaluation: yes, return date: 30-aug-2021.Device evaluated by mfr: no, device evaluation anticipated, but not yet begun dev rtn to mfr? yes.Mfg date: 17-apr-2021.Labeled for single use: no.(b)(4).Heartware ventricular assist system - battery model #: 1650 / catalog #: 1650 / expiration date: 31-dec-2021 / serial or lot#: (b)(4) udi #: (b)(4).Device available for evaluation: yes, return date: 30-aug-2021.Device evaluated by mfr: no, device evaluation anticipated, but not yet begun.Dev rtn to mfr? yes.Mfg date: 19-dec-2020.Labeled for single use: no.(b)(4).Heartware ventricular assist system - battery model #: 1650 / catalog #: 1650 / expiration date: 31-dec-2021 / serial or lot#: (b)(4) udi #: (b)(4) device available for evaluation: yes, return date: 30-aug-2021.Device evaluated by mfr: no, device evaluation anticipated, but not yet begun.Dev rtn to mfr? yes.Mfg date: 19-dec-2020.Labeled for single use: no.(b)(4).Heartware ventricular assist system - battery model #: 1650 / catalog #: 1650 / expiration date: 31-dec-2021 / serial or lot#: (b)(4) udi #: (b)(4) device available for evaluation: yes, return date: 30-aug-2021.Device evaluated by mfr: no, device evaluation anticipated, but not yet begun.Dev rtn to mfr? yes.Mfg date: 23-dec-2020.Labeled for single use: no.(b)(4).Heartware ventricular assist system - battery.Model #: 1650 / catalog #: 1650 / expiration date: 30-ap-2022 / serial or lot#: (b)(4) udi #: (b)(4) device available for evaluation: no.Device evaluated by mfr: no, device evaluation anticipated, but not yet begun.Mfg date: 16-apr-2021.Labeled for single use: no.(b)(4).Heartware ventricular assist system - battery model #: 1650 / catalog #: 1650 / expiration date: 31-dec-2020 / serial or lot#: (b)(4) udi #: (b)(4).Device available for evaluation: no.Device evaluated by mfr: no, device evaluation anticipated, but not yet begun.Mfg date: 31-dec-2021.Labeled for single use: no.(b)(4).If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

A supplemental report is being submitted for investigation completion.Product event summary: one (1) controller (b)(6) and six (6) batteries (bat935262, bat932289, bat932288, bat932705, bat935200, bat932286) were returned for evaluation.Various analyses were conducted and reviewed to evaluate the performance of the devices in relation to the reported event.Failure analysis of the returned batteries revealed that the devices passed visual inspection and functional testing.Failure analysis of (b)(6) revealed that the controller passed visual inspection and functional testing.Supplemental testing was performed on the controller and the test results revealed that the gold-plating of the pins were worn, exposing the base metal.The exposure of the base metal is susceptible to the effects of corrosion.Log file analysis revealed that the controller 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 several momentary disconnections involving bat935262, bat932289 and bat932286.Momentary disconnections will result in an audible tone or 'beep'.Additionally, analysis of the alarm files revealed a low flow alarm on (b)(6) 2021 at 23:53:39 hours.As a result, the reported event was confirmed.The batteries were lubricated prior to release.The most likely root cause of the reported beeps can be attributed to momentary disconnections due to temporary corrosion of the controller-port/power-source pins.Based on the risk documentation, possible causes of the reported low flow alarms 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.Additional products: bat935262- battery h3: yes dev rtn to mfr? yes h6: fda method code(s): b01, b15 h6: fda results code(s): c04 h6: fda conclusion code(s): d02 bat932289- battery h3: yes dev rtn to mfr? yes h6: fda method code(s): b01, b15 h6: fda results code(s): c04 h6: fda conclusion code(s): d02 bat932288- battery h3: yes dev rtn to mfr? yes h6: fda method code(s): b01, b15 h6: fda results code(s): c19 h6: fda conclusion code(s): d14 bat932705- battery h3: yes dev rtn to mfr? yes h6: fda method code(s): b01, b15 h6: fda results code(s): c19 h6: fda conclusion code(s): d14 bat935200- battery h3: yes dev rtn to mfr? yes h6: fda method code(s): b01, b15 h6: fda results code(s): c19 h6: fda conclusion code(s): d14 bat932286- battery h3: yes dev rtn to mfr? yes h6: fda method code(s): b01, b15 h6: fda results code(s): c04 h6: fda conclusion code(s): d02 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.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

A supplemental report is being submitted for updates to the device analysis and investigation summary.The product event summary has been updated as follows: product event summary: one (1) controller (b)(6) and six (6) batteries (b)(6) were returned for evaluation.Various analyses were conducted and reviewed in order to evaluate the performance of the devices in relation to the reported event.Failure analysis of the returned batteries revealed that the devices passed visual inspection and functional testing.Internal inspection of the batteries did not reveal any anomalies.Of note, the batteries (b)(6) are in scope of fa1257, which was initiated for batteries with a welding defect in a spot weld of the nickel strip that connects the 5x and 3x cell pack.While (b)(6) are in scope of fa1257, internal visual inspection did not reveal any anomalies associated with the battery welding.Failure analysis of (b)(6) revealed that the controller passed visual inspection and functional testing.Internal inspection of the controller did not reveal any anomalies.Supplemental testing was performed on the controller and the test results revealed that the gold-plating of the pins were worn, exposing the base metal.The exposure of the base metal is susceptible to the effects of corrosion.Log file analysis revealed that the controller 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 several momentary disconnections involving (b)(6).Momentary disconnections will result in an audible tone or 'beep'.Additionally, analysis of the alarm files revealed a low flow alarm on (b)(6) 2021 at 23:53:39 hours.As a result, the reported event was confirmed.The batteries were lubricated prior to release.The most likely root cause of the reported beeps can be attributed to momentary disconnections due to temporary corrosion of the controller-port/power-source pins.Capa pr00574181 is investigating momentary disconnections.Based on the risk documentation, possible causes of the reported low flow alarms 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 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.

• Brand Name: HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0
• 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: 12407813
• MDR Text Key: 280604300
• Report Number: 3007042319-2021-06182
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00888707000475
• UDI-Public: 00888707000475
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/20/2023

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: 07/31/2019
• Device Model Number: 1420
• Device Catalogue Number: 1420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/24/2021
• Initial Date FDA Received: 09/01/2021
• Supplement Dates Manufacturer Received: 10/22/2021; 04/07/2023
• Supplement Dates FDA Received: 10/28/2021; 04/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/11/2018
• 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: 1103 VAD
• Patient Age: 74 YR
• Patient Sex: Male