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U.S. Department of Health and Human Services


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Catalog Number 1403US
Device Problems Failure to Pump (1502); Pumping Stopped (1503); Power Problem (3010)
Patient Problems Dizziness (2194); Anxiety (2328)
Event Date 05/15/2017
Event Type  malfunction  
Manufacturer Narrative
Serial# (b)(4). If information is provided in the future, a supplemental report will be issued.
Manufacturer Narrative
Product event summary: one controller, (b)(4), was returned for evaluation. One controller ((b)(4)) was not returned for evaluation. A review of the manufacturing records confirmed that (b)(4) met all requirements for release. Various analyses were conducted and reviewed in order to evaluate the performance of the returned controller ((b)(4)) in relation to the reported event. Failure analysis of the returned device revealed that the controller passed visual examination. Functional testing revealed that the "no power" alarm failed to sound when both power sources were disconnected. Evaluation of the internal nickel-metal hydride (nimh) battery revealed that one of the cell's voltage level was below what was expected. As a result, the most likely root cause can be attributed to a faulty internal nimh battery. An internal investigation evaluated "no power" audible alarm failures. Analysis of the controller log files revealed that the real time clock was reset to zero (year 2000). The controller was able to retain the date and the time when the real time clock was adequately charged. As a result, the most likely root cause of the reported issue with the real time clock can be attributed to an extended period of time where the controller, (b)(4), was not connected to an external power source, causing the real time clock to deplete. Analysis of the returned controller's log files revealed multiple power-up events and a vad disconnect alarm; it's likely that the driveline cable was disconnected from the controller when the controller was powered up. This observation correlates with the reported controller exchange incident. The time of those events and alarm cannot be determined due to the controller's real time clock that was reset to zero. Log files of the controller in use during the reported event, (b)(4), revealed that the controller did not contain the software master record (smr) software. A review of the data log files revealed premature power switching events. The most likely root cause of the reported power switching events can be attributed to communication errors between the controller and battery. An internal investigation evaluated communication errors. Additional products: controller (b)(4). Device evaluated by mfr: yes. If information is provided in the future, a supplemental report will be issued.
Manufacturer Narrative
Con005625 - controller / catalog number 1403us / expiration date: unknown. Device available foe evaluation: yes, 05/26/2017. Device evaluation anticipated, but not yet begun. Mfg date: 05/31/2016. (b)(4). 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 controller is a microprocessor unit that controls and manages the system. It sends power and operating signals to the blood pump and collects information from the pump. The controller requires two power sources for safe operation: either two batteries, or one battery and an ac adapter or dc adapter. The instructions for use (ifu) and patient manual include a reference guide for both visual and tone alarms including potential causes and actions to take. They also outline the steps for handling and properly connecting power sources, including ensuring proper alignment, as well as instructions not to twist or force connections together in order to prevent damages. It is outlined to inspect the power connections and pins once a week, one at a time when changing the power source. The ifu further warns that damaged equipment should be reported to the manufacturer and inspected. Additionally, there is a warning to keep spare, fully charged batteries and back up controller available at all times. The steps for exchange of batteries and controllers are outlined. 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. 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. According to the ifu, users are instructed to input the current date and time when setting up both the primary and backup controllers. According to the ifu, controllers are expected to function for at least one year. The real time clock has a different power source from the pump parameters display and alarms. Heartware will submit a supplemental report when new facts arises which materially alters information submitted in a previous mdr report. Product has been not returned.
Event Description
It was reported that the patient complained of battery switching, however this was not confirmed by log files. The logfiles did note pump stops and the decision was made to change the controller. The backup controller was an older controller. When the coordinator was getting ready to do the controller exchange they failed to disconnect the power to the controller before putting it on the patient; rather it was set up as a primary instead of as a backup. The controller did not restart the pump when it was attached and the patient became dizzy. The original controller was switched back on. The backup controller had an internal clock error and was considered past its useful life. It was taken out of service. Education was provided to the coordinators on setting up controllers. The patient was very upset and initially refused any further exchanges and the original controller remained in use. The controller was exchanged two days later.
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Manufacturer (Section D)
14400 nw 60th avenue
miami lakes FL 33014 3105
MDR Report Key6770657
MDR Text Key248824065
Report Number3007042319-2017-01777
Device Sequence Number1
Product Code DSQ
Combination Product (y/n)N
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Remedial Action Recall
Type of Report Initial,Followup,Followup
Report Date 10/10/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/07/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2017
Device Catalogue Number1403US
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/05/2018
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberZ-1917-2015

Patient Treatment Data
Date Received: 08/07/2017 Patient Sequence Number: 1
PUMP - (B)(4)