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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HEARTWARE HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP CIRCULATORY ASSIST SYSTEM

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HEARTWARE HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP CIRCULATORY ASSIST SYSTEM Back to Search Results
Model Number 1104
Device Problems Failure to Pump (1502); Pumping Stopped (1503); Pumping Problem (3016)
Patient Problems Thrombus (2101); No Consequences Or Impact To Patient (2199)
Event Date 07/29/2017
Event Type  Injury  
Manufacturer Narrative
Additional devices added to this event: serial # (b)(4), catalog# 1420 exp. Date:03/31/2018. Device available for evaluation: no, device evaluated by mfr: not returned to manufacturer, labeled for single use: no, (b)(4). Serial # (b)(4), catalog# 1420 exp. Date:03/31/2018. Device available for evaluation: no, device evaluated by mfr: not returned to manufacturer, labeled for single use: no, (b)(4). It was further reported that there was suspected thrombus ingestion which made the pump unable to restart. A pump exchange is planned in the near future. No patient complications have been reported as a result of this event. No additional information is available. Heartware will submit a supplemental report when new facts arises which materially alters information submitted in a previous mdr report.
 
Manufacturer Narrative
Conclusion: pump was not returned for evaluation. (b)(4) were returned for evaluation. A review of the manufacturing documentation confirmed that the associated pump met all requirements for release. Various analyses were conducted and reviewed in order to evaluate the performance of the controllers in relation to the reported event. Failure analysis of the returned devices revealed that the controllers passed visual examination and functional testing. The reported pump stop event was confirmed through log file analysis. Log file analysis revealed a decrease in estimated flow of approximately 2 liters per minute (l/min) beginning (b)(6) 2017, followed by a rise in power consumption. The alarm file of (b)(4) revealed that 83 low flow alarms were logged on (b)(6) 2017, 3 high watt alarms were logged on (b)(6) 2017, and 25 vad stopped alarms were logged on (b)(6) 2017; the vad stopped alarms were caused by the pump failing to restart. As a result, the reported "failure of the pump to restart" was confirmed. In addition, a review of (b)(4) event files revealed several controller power up events. The controller power up events were likely d ue an attempt to exchange to the backup (b)(4) and an attempt to troubleshoot the alarms. Analysis of the log files pertaining to the backup controller, (b)(4), revealed 10 vad stopped alarm logged on (b)(6) 2017; several of the vad stopped alarms were due to the pump failing to restart after several attempts. There is no evidence to suggest that a device malfunction caused or contributed to the reported event. Based on the available information, the low flows may be attributed to thrombus at the inflow cannula which likely got ingested into the pump, further triggering high watt alarms, thereby causing the pump to stop. 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.
 
Event Description
It was further reported that the vad was explanted.
 
Manufacturer Narrative
Product event summary #n/a. Concomitant medical products: product id: 1420-mcs, serial#: (b)(4). Product id: 1420-mcs, serial#: (b)(4). Additional devices added to this event: serial #: (b)(4). Device available for evaluation: yes, 2017-09-25. Device evaluated by mfr: yes. (b)(4). Product event summary: the reported event details narrative: information indicates that there was suspected thrombus ingestion which made the pump unable to restart. Per vad coordinator patient came into clinic due to a pump that did not restart, patient¿s wife described several alarms before pump stopped and could not be restarted, even the backup controller failed starting the pump. ¿ was confirmed via log files. The controller passed visual and functional testing. During review of controller serial (b)(4) log files revealed that this controller was the backup controller. The controller log alarm file revealed a vad stop alarm logged on (b)(6) 2017 at 08:59:36 hours. Additional devices added to this event: serial #: (b)(4). Device available for evaluation: yes, 2017-09-25. Device evaluated by mfr: yes. (b)(4). Product event summary: the reported event details narrative: information indicates that there was suspected thrombus ingestion which made the pump unable to restart. Per vad coordinator patient came into clinic due to a pump that did not restart, patient¿s wife described several alarms before pump stopped and could not be restarted, even the backup controller failed starting the pump. ¿ was confirmed via log files. The controller passed visual and functional testing. During review of controller serial (b)(4) log files revealed, a high watts alarm logged on (b)(6) 2017 at 06:42:37 hours followed by the vad stop alarm logged on (b)(6) 2017 at 08:56:55 hours. If information is provided in the future, a supplemental report will be issued.
 
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. 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 the patient came into clinic due to a pump that would not restart. The patient's wife described several alarms before pump stopped and could not be restarted; even the backup controller failed starting the pump. The patient was transported to hospital and a brand new controller was used to try and restart the pump but also failed. The patient was admitted to the intensive care unit (icu) and prepped for a pump exchange planned for the following week. The patient remained stable and log files showed several low flow alarms followed by a massive increase in power and then no operation. The left ventricular assist device (lvad) remains implanted. No patient complications have been reported as a result of this event.
 
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Brand NameHEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP
Type of DeviceCIRCULATORY ASSIST SYSTEM
Manufacturer (Section D)
HEARTWARE
14400 nw 60th avenue
miami lakes FL 33014 3105
MDR Report Key6812342
MDR Text Key253207811
Report Number3007042319-2017-02779
Device Sequence Number1
Product Code DSQ
Combination Product (y/n)N
PMA/PMN Number
P100047
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 03/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/22/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2018
Device Model Number1104
Device Catalogue Number1104
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/28/2019
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 08/22/2017 Patient Sequence Number: 1
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