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

Model Number 1420

Device Problems Device Inoperable (1663); Battery Problem (2885); Power Problem (3010)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/13/2018

Event Type  malfunction  

Manufacturer Narrative

Other devices involved in this event: heartware ventricular assist system - battery, battery / (b)(4)/ model #: 1650de / expiration date: 2018-08-31 udi #: (b)(4), mfg date: 2017-08-31, (b)(4).Heartware ventricular assist system - battery, battery / (b)(4) / model #: 1650de / expiration date: 2018-07-31, udi #: (b)(4), mfg date: 2017-07-31.(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient had power switching and a pump stop when changing a battery.The patient was attached to two batteries.One battery became low and power was switched to the second battery.When the patient disconnected the depleted battery to change it, the controller lost power.The patient was asymptomatic and able to reattach the battery.No patient complications have been reported as a result of this event.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Product event summary: one controller was not returned for evaluation.Two batteries (bat584580, bat584050) 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 examination and functional testing.Log file analysis revealed that the controller in use during the reported event 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 premature power switching events that were due to momentary disconnections involving bat584580 and bat584050, as well as one premature power switching event that was due to a communication error.Analysis of the event log file revealed a controller power up event on 13/mar/2018 at 15:39:20.The data point recorded prior to the loss of power revealed that bat584580 was connected to power port one (1) and another battery was connected to power port two (2) with 23% relative state of charge (rsoc); bat584580 had experienced momentary disconnections within the preceding 15 minutes.The data point recorded after the loss of power revealed that bat584580 was connected to power port one (1) and bat584050 was connected to power port two (2).The controller was without power for 9 seconds.As a result, the reported event was confirmed.A possible root cause of the loss of power can be attributed to a disconnection of both power sources and/or to an intermittent disconnection on one or both power sources.The most likely root cause of the premature power switching event can be attributed to momentary disconnections and communication errors between the controller and batteries.An internal investigation was initiated to capture events involving the controller losing power.An internal investigation evaluated momentary disconnections.Additional products: d4: catalog #: 1650de / serial #: bat584580 h3: yes dev rtn to mfr? yes h6: fda method code(s): 4112 h6: fda conclusion code(s): 12 d4: catalog #: 1650de / serial #: bat584050 h3: yes dev rtn to mfr? yes h6: fda method code(s): 4112 h6: fda conclusion code(s): 12 this event was assessed and is being reported as part of a retrospective review of log file data.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

Product event summary: the controller, (b)(4) was not returned for evaluation, two (2) batteries (b)(4) 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 examination and functional testing.Log file analysis revealed that the controller, (b)(4) 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 files revealed several premature power switching events that were due to momentary disconnections involving (b)(4).Log files also revealed a controller power-up and motor start event on (b)(6), 2018 at 15:39:20.The data point prior to the controller power up was logged at 15:26:25 and revealed that (b)(4) was connected to power port 1 and (b)(4) as connected to power port 2 with 23% relative state of charge (rsoc); (b)(4) had experienced momentary disconnections within the preceding 15 minutes.The data point after the controller power up event was logged, at 15:39:55, revealed that (b)(4).Was connected to power port 1 and (b)(4).Was connected to power port 2 of the controller.No alarms were logged near (b)(6), 2018.As a result, the reported event was confirmed.Based on log file analysis, a possible root cause of the loss of power can be attributed to a disconnection of both power sources and/or due to a momentary disconnection between the controller and battery.The most likely root cause of the reported "power switching" event can be attributed to momentary disconnections between the controller and batteries.An internal investigation is evaluating momentary disconnections.Battery, (b)(4).D4 expiration date: 2018-08-31 udi#: (b)(4).D10: yes, return date: 2018-05-31 h3: yes h4: mfg date: 2017-08-31 h6 fda method code(s): 10, 23, 38 h6 fda results code(s): 3213 h6 fda conclusion code(s): 25 battery, (b)(4).D4 expiration date: 2018-07-31 udi#: (b)(4).D10: yes, return date: 2018-05-31 h3: yes h4: mfg date: 2017-07-31 h6 fda method code(s): 10, 23, 38 h6 fda results code(s): 3213 h6 fda conclusion code(s): 25 medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.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 in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees 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 reporting pursuant to part 803.Medtronic objects to the use of these words and others like it 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 - CONTROLLER 2.0
• Type of Device: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 7414697
• MDR Text Key: 105516930
• Report Number: 3007042319-2018-01394
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00888707000420
• UDI-Public: 00888707000420
• Combination Product (y/n): N
• PMA/PMN Number: P100047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2018
• Device Model Number: 1420
• Device Catalogue Number: 1420
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1903-2018
• Patient Sequence Number: 1
• Treatment: (B)(4).
• Patient Age: 52 YR