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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HEARTWARE, INC HEARTWARE® VENTRICULAR ASSIST SYSTEM -PUMP VENTRICULAR (ASSISST) BYPASS

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HEARTWARE, INC HEARTWARE® VENTRICULAR ASSIST SYSTEM -PUMP VENTRICULAR (ASSISST) BYPASS Back to Search Results
Catalog Number 1104
Device Problem Failure to Pump (1502)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/24/2017
Event Type  malfunction  
Manufacturer Narrative
Conclusion: the driveline extension cable # (b)(4) were returned for evaluation. (b)(4) was not returned for evaluation. A data cable with unknown lot number was shipped to (b)(4) prior to the device being added to the complaint record. As a result, the data cable is unavailable for analysis. Various analysis were conducted and reviewed in order to evaluate the performance of the extension cable and controller in relation to the reported event. A review of the manufacturing documentation confirmed that the associated pump met all requirements for release. A review of the manufacturing documentation of the data cable could not be performed due to the lot number being unknown. Failure analysis of the returned controller revealed that the device passed visual inspection and functional testing. Visual examination of the driveline extension cable connector did not identify any evidence of contamination, damage or other anomalies that may have compromised the functionality of the device. Functional testing revealed that the locking mechanism of driveline extension cable worked as intended. Furthermore, a supplemental test was performed in an attempt to replicate the reported event with the returned driveline extension cable, controller and representative samples of motor fixture and a battery; the system performed as intended. The speed could be changed successfully; therefore the reported event could not be replicated. A review of log files for (b)(4) revealed one speed change from 1800 rpm to 2400 rpm on (b)(6) 2017. Applicable risk documentation and experience with events of similar circumstances were considered; a possible root cause of the reported event can be attributed, but not limited, to a ram memory failure of the monitor, a data cable failure, a monitor-to-controller communication error and/or due to an intermittent connection between the monitor and controller. Other device involved in this event; medical device: driveline extension cable - (b)(4). Device evaluated by manufacturer: yes. (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Other device involved in this event; driveline extension cable - 1280317 / catalog number 100 / expiration date:04/30/2018. Device available for evaluation: yes (06/30/2017), device evaluated by manufacturer: no, device evaluation anticipated, but not yet begun. Labeled for single use: no. Connection issue. 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 by the ventricular assist device (vad) coordinator that problems were experienced during implant. Initial start-up of the pump after implant was uneventful but speed was not able to be increased at first attempt. Several attempts were required before successfully managing to increase or decrease speed. "controller update failed value not changed" was displayed when unsuccessful. The same problem was experienced when trying to set the alarm limits. All connections were checked. Following removal of the extension cable, there was no difficulty in setting alarm limits. Speed and alarm limits were able to be set on the back-up controller without any issues. This resulted in a procedural delay. The pump remains in use. No patient complications have been reported as a result of this event.
 
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Brand NameHEARTWARE® VENTRICULAR ASSIST SYSTEM -PUMP
Type of DeviceVENTRICULAR (ASSISST) BYPASS
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
anne schilling
8200 coral sea st ne
mounds view, MN 55112-3105
7635052036
MDR Report Key6801179
MDR Text Key264804376
Report Number3007042319-2017-02706
Device Sequence Number1
Product Code DSQ
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
P100047
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/02/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/17/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2019
Device Catalogue Number1104
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/11/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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