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

Model Number 1650DE

Device Problems Contamination (1120); Battery Problem (2885); Contamination /Decontamination Problem (2895)

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

Event Type  malfunction  

Event Description

It was reported that the patient reported the batteries exhibited permanent power switching on port one. it was noted that the patient never used a power supply unit, only during the night from yesterday to today.This tends to avoid switching. the batteries were replaced, and it was also noted that the contacts were dirty both on the batteries and controller.  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.  h6: the codes present in section h6 correspond to components/products that comprise the reported event.Additional products: d1: heartware ventricular assist system ¿battery d4: model#: 1650 / catalog#: 1650 / expiration date: 31-march-2024/ serial#: (b)(6), udi#: (b)(4), d9: no  h3: no, device evaluation anticipated, but not yet begun, h4: mfg date: 14-march-2023, h5: no, d1: battery, d4: model#: 1650 / catalog#: 1650 / expiration date: 31-march-2024  / serial#: (b)(6), udi#: (b)(4), d9: no,  h3: no, device evaluation anticipated, but not yet begun, h4: mfg date: 13-march-2023, h5: no,  d1: battery d4: model#: 1650 / catalog#: 1650 / expiration date: 31-march-2024/ serial#: (b)(6), udi#: (b)(4), d9: no, h3: no, device evaluation anticipated, but not yet begun, h4: mfg date: 14-march-2023, h5: no,  d1: battery d4: model#: 1650 / catalog#: 1650 / expiration date: 31-march-2024 / serial#: (b)(6), udi#: (b)(4), d9: no,  h3: no, device evaluation anticipated, but not yet begun h4: mfg date:  14-march-2023 h5: no 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 patient reported the batteries exhibited permanent power switching on port one.It was noted that the patient never used a power supply unit, only during the night from yesterday to today.This tends to avoid switching.It was also noted that the contacts were dirty, on both the batteries and the controller.The batteries were replaced, and the controller remain in use.No patient complications have been reported as a result of this event.

Manufacturer Narrative

A supplemental report is being submitted for a correction.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.

Manufacturer Narrative

A supplemental is being submitted for a correction.Additional products: d1: heartware ventricular assist system ¿ controller d4: model#: 1420 / catalog#: 1420 / expiration date: 31-may-2022 / serial#: (b)(6) udi#: (b)(4) d9: no h3: no, device evaluation anticipated, but not yet begun h4: mfg date:17-may-2021 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.

Manufacturer Narrative

A supplemental report is being submitted for device evaluation.Product event summary: the controller (b)(6) was not returned for evaluation.Five (5) batteries (b)(6) were returned for evaluation.A review of the manufacturing documentation confirmed that the associated controller met all requirements for release.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 devices revealed that the batteries passed visual inspection and functional testing.Internal inspection of the batteries revealed no anomalies.Visual inspection of the batteries revealed a dark substance on the battery pins caused by the lubrication.It is likely the lubricant was perceived as the reported foreign material on the batteries.Analysis of the data log file revealed several premature power switching events that were due to momentary disconnections involving (b)(6).As a result, the reported power switching event and foreign material on the batteries event were confirmed.The reported contamination in the controller power port could not be confirmed.Applicable risk documentation and experience with events of similar circumstances were considered; a possible root cause of the reported controller power port contamination can be attributed to the handling of the device.Based on an investigation conducted under capa pr00574181 and the available information, the most likely root cause of the reported power switching event can be attributed to momentary dis connections due to fretting corrosion of the controller-port/power-source pins, contamination on the controller receptacle sockets/power source pins, and/or a large spring gap between the controller receptacle spring and trough caused by a damaged receptacle.Even though this capa is now closed, (b)(6) and associated batteries fall in scope of this capa.Additional products: d4: serial or lot#: (b)(6) d9: yes, return date: 11-dec-2023 h3: yes dev rtn to mfr? yes h6: the codes present in section h6 correspond to components/products that comprise the reported event.D4: serial or lot#: (b)(6) d9: yes, return date: 11-dec-2023 h3: yes dev rtn to mfr? yes h6: the codes present in section h6 correspond to components/products that comprise the reported event.D4: serial or lot#: (b)(6) d9: yes, return date: 11-dec-2023 h3: yes dev rtn to mfr? yes h6: the codes present in section h6 correspond to components/products that comprise the reported event.D4: serial or lot#: (b)(6) d9: yes, return date: 11-dec-2023 h3: yes dev rtn to mfr? yes h6: the codes present in section h6 correspond to components/products that comprise the reported event.D4: serial or lot#: (b)(6) h3: yes h6: the codes present in section h6 correspond to components/products that comprise the reported event.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.Product analysis # (b)(4) :the returned battery (b)(6) passed visual inspection and functional testing.Visual inspection revealed a dark substance on the battery pins caused by the lubrication.Internal inspection revealed no anomalies.Analysis of the data log file revealed several premature power switching events that were due to momentary disconnections involving (b)(6).Continuation of d10: product id (b)(4) -controller lot# serial# (b)(6) implanted: explanted: product id (b)(4) lot# serial# (b)(6) implanted: explanted: product id (b)(4) lot# serial# (b)(6) implanted: explanted: product id 1650de lot# serial# (b)(6) implanted: explanted: product id (b)(4) lot# serial# (b)(6) implanted: explanted: 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.

• 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: 18141588
• MDR Text Key: 328237105
• Report Number: 3007042319-2023-04521
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00763000629717
• UDI-Public: 00763000629717
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2024
• Device Model Number: 1650DE
• Device Catalogue Number: 1650DE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/13/2023
• 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
• Treatment: 1104 VAD