MAUDE Adverse Event Report: HEARTWARE, INC HEARTWARE VENTRICULAR ASSIST SYSTEM; CIRCULATORY ASSIST SYSTEM

Catalog Number 1407GB

Device Problems Disconnection (1171); Device Inoperable (1663); Use of Device Problem (1670); Connection Problem (2900); Protective Measures Problem (3015)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2017

Event Type  malfunction  

Manufacturer Narrative

This device is used for treatment not diagnosis.The ventricular assist system is indicated for use as a bridge to cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure.The system is designed for in-hospital and out-of-hospital settings.The device labeling warns that disconnecting the controller from the driveline and disconnecting both power sources (batteries and ac or dc adapter) at the same time will stop the pump.At least one power source must be connected at all times.The instructions for use (ifu) and patient manual provide clear instructions to the user on proper usage and care of the hvad system.Moreover, the ifu provides instruction to further educate the patient about product safety, alarm management, and hvad support; additional guidelines instruct the user on how to detect and react to a 'vad stop'.A "vad stopped" alarm will activate if the pump driveline is not connected to the new controller within 10 seconds.This alarm will resolve once the pump driveline is connected.Heartware will submit a supplemental report when new facts arises which materially alters information submitted in a previous mdr report.

Event Description

It was reported that at night, the patient got up to change the battery at power port two (2).However, after changing the battery he still heard the controller alarming.Without checking closely, he had mistakenly removed the functional ac adapter at power port one (1) which caused the pump stop.The patient did not report any dizziness or other discomfort while the pump stopped, as he was able to reconnect the power source and restart the pump.The ventricular assist device (vad) coordinator was informed on 16jan2017 during clinical follow up.A pump start event was found on (b)(6) 2017, 02:48:47 by log file.Per the logs for the battery, there were a few times that the battery was disconnected and reconnected to the same port within a 15-minute interval.The controller was connected to an ac adapter at port one (1) before the double power disconnection.There was no indication of a faulty ac adapter and the patient or vad coordinator reported no abnormal ac adapter behavior.Patient has stopped using the battery (b)(4) since (b)(6) 2017.Patient is fine and no conditions have changed.The vad coordinator tested the defective battery and found that it was also unable to power up a controller despite it was fully charged.The battery was replaced.There was no controller exchanged.

Manufacturer Narrative

It was reported that the patient experienced a loss of power and multiple disconnections with battery (b)(4).Additionally, it was reported that battery (b)(4) was unable to power a controller.Controller (b)(4) was returned for evaluation.Battery (b)(4) was not returned, despite multiple attempts to obtain the device were made.A review of the manufacturing documentation revealed that both units met all requirements for release.Log file analysis revealed a controller power up and motor start event on (b)(6) 2017 at 02:48:41 and 02:48:47; respectively.The data point prior to the controller power up event (at 02:43:46) revealed that a controller ac adapter was connected to power port one (1) and that battery (b)(4) was connected to power port two (2) with (b)(4) percent ((b)(4)) relative state of charge (rsoc).The data point after the controller power up (at 03:03:40) revealed that a controller ac adapter was connected to power port one (1) and battery (b)(4) was connected to power port two (2).Both power sources experienced a disconnection and reconnection within the preceding 15-minute interval.Log file analysis also confirmed multiple momentary disconnections involving battery (b)(4).No alarms were recorded that could be related to the reported event.The most likely root cause of the controller power up event can be attributed to a disconnection of both power sources.Failure analysis of the controller revealed that the device failed visual inspection due to a loose power port one (1) and power port two (2) connector.This observation is not related to the reported event.A possible root cause of the loose connectors may be attributed to a shift in the manufacturing process.Failure analysis of the controller also revealed that the device failed functional testing.Initial testing of the device indicated that the controller was able to sound for the "no power" alarm.Additional testing of the controller was performed, which included exposing the controller to a temperature of 50°c to determine if the "no power" alarm would still sound under higher environmental (ambient) temperature conditions.Results revealed that the alarm failed to sound once both power sources were disconnected.During the analysis of the controller, a fairchild mosfet was measured at a high temperature, but still within the manufacturing temperature range between -55oc to 150oc.The heat generated by the mosfet was adding to the environmental (ambient) temperature, causing the "no power" alarm's circuit thermal fuse to open, resulting in a failure of the "no power" alarm.Once the controller was allowed to operate at cooler temperatures, the thermal fuse was able to re-cover and close the circuit, and the "no power" alarm regained functionality.This finding is not related to the reported event.A possible root cause reported controller not receiving power despite the fact that the battery was connected can be attributed to momentary disconnections between the controller and the battery and/or to a battery malfunction.The battery, however, was not returned for evaluation.The most likely root cause of the loss of power can be attributed to a disconnection of both power sources.Heartware has opened an internal investigation to address momentary disconnections.(b)(4) - controller: an internal investigation has been opened by the supplier to address investigating loose connectors.(b)(4) - battery / catalog number 1650de / expiration date 01-31-2017 device available for evaluation: no, device evaluated by manufacturer: no, not returned to manufacturer device manufacture date: 01-31-2016, labeled for single use: no.Battery issue.Analysis of data log(s) (b)(4); manufacturing review (b)(4); actual device not evaluated (b)(4); interoperability problem (b)(4); conclusion code(s): quality system deficiency (b)(4); heartware will submit a supplemental report when new facts arises which materially alters information submitted in a previous mdr report.

Manufacturer Narrative

(b)(4) - battery.(b)(4) 2017.Device evaluation anticipated, but not yet begun.Heartware will submit a supplemental report when new facts arises which materially alters information submitted in a previous mdr report.

Manufacturer Narrative

Additional information received: it was further reported that the controller was exchanged.(b)(4). it was reported that the patient experienced a loss of power and multiple disconnections with (b)(4).Additionally, it was reported that (b)(4) was unable to power a controller.(b)(4) was returned for evaluation.(b)(4) was also returned.A review of the manufacturing documentation revealed that both units met all requirements for release.Log file analysis revealed a controller power up and motor start event on (b)(6) 2017 at 02:48:41 and 02:48:47; respectively.The data point prior to the controller power up event (at 02:43:46) revealed that a controller ac adapter was connected to power port 1 and that (b)(4) was connected to power port 2 with 97% relative state of charge (rsoc).The data point after the controller power up (at 03:03:40) revealed that a controller ac adapter was connected to power port 1 and (b)(4) was connected to power port 2.Both power sources experienced a disconnection and reconnection within the preceding 15 minute interval.Log file analysis also confirmed multiple momentary disconnections involving (b)(4).No alarms were recorded that could be related to the reported event.The most likely root cause of the controller power up event can be attributed to a disconnection of both power sources.Failure analysis of the controller revealed that the device failed visual inspection due to a loose power port 1 and power port 2 connector.This observation is not related to the reported event.A possible root cause of the loose connectors may be attributed to a shift in the manufacturing process.Failure analysis of the controller also revealed that the device failed functional testing.Initial testing of the device indicated that the controller was able to sound for the "no power" alarm.Additional testing of the controller was performed, which included exposing the controller to a temperature of 50°c to determine if the "no power" alarm would still sound under higher environmental (ambient) temperature conditions.Results revealed that the alarm failed to sound once both power sources were disconnected.  during the analysis of the controller, a fairchild mosfet was measured at a high temperature, but still within the manufacturing temperature range between -55oc to 150oc.The heat generated by the mosfet was adding to the environmental (ambient) temperature, causing the "no power" alarm's circuit thermal fuse to open, resulting in a failure of the "no power" alarm.Once the controller was allowed to operate at cooler temperatures, the thermal fuse was able to re-cover and close the circuit, and the "no power" alarm regained functionality.This finding is not related to the reported event.A possible root cause reported controller not receiving power despite the fact that the battery was connected can be attributed to momentary disconnections between the controller and the battery and/or to a battery malfunction.The most likely root cause of the loss of power can be attributed to a disconnection of both power sources.Heartware will submit a supplemental report when new facts arises which materially alters information submitted in a previous mdr report.

Manufacturer Narrative

Other devices involved in this event: battery / (b)(4).If information is provided in the future, a supplemental report will be issued.

• Brand Name: HEARTWARE VENTRICULAR ASSIST SYSTEM
• Type of Device: CIRCULATORY ASSIST SYSTEM
• Manufacturer (Section D): HEARTWARE, INC; 14400 nw 60th avenue; miami lakes FL 33014 3105
• Manufacturer (Section G): HEARTWARE, INC; 14400 nw 60th avenue; miami lakes FL 33014 3105
• Manufacturer Contact: nathalie nunez ; 14400 nw 60th avenue; miami lakes, FL 33014-3105 ; 3053641538
• MDR Report Key: 6316018
• MDR Text Key: 67298220
• Report Number: 3007042319-2017-00399
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: MY
• 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
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2015
• Device Catalogue Number: 1407GB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1