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

Catalog Number 1104

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Code Available (3191)

Event Date 06/02/2013

Event Type  Injury  

Manufacturer Narrative

The hvad is used for treatment not diagnosis.The hvad pump drive line cable ((b)(4)) was not returned to manufacturer for analysis because it remains implanted.Controller log files revealed a rise in power and electrical fault alarms that were due to a wire not being connected.The reported event, driveline wire damage, was confirmed visually in the field by the heartware clinical engineer.It is possible that when the patient dropped his controller bag in the shower, the tensile force may have caused the pins to be disconnected from the contact block.After the driveline splice procedure was performed, the power and flow returned to normal and the patient is reported to be doing fine.The root cause for the reported driveline connector damage can be attributed to inadequate connector design specifications that does not account excessive pull force that may be exerted on to the driveline cable, causing the connector pins to recess and interrupt pump operation.The manufacturer has an open internal investigation for the retraction of the driveline cable splice connector pins.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, including transportation.Patient manual ifu provides an instruction and also a caution note: do not pull, twist or kink the driveline or power cables, especially while sitting, getting out of bed, adjusting controller or power sources, or when using the shower bag.It also cautions, "keep extra driveline length tucked under clothing or secured with an abdominal binder or dressing.Do not let any portion of driveline hang freely where it might get caught on external items such as doorknobs or the corners of furniture.(b)(4).

Event Description

It was stated that the patient was taking a shower.He dropped his controller bag and it fell down and yanked on the cable.This patient had a previous splice repair done on (b)(6) 2012.Immediately afterwards the controller gave off a yellow alarm and showed an "electrical fault" message.Pump flow and power rose significantly.The patient was taken to the hospital for safety reasons.While in the hospital, no external damage could be seen.Splice location was secured to prevent any further tensile stress to it.Log file analysis showed "sys_front_over_current_trip".The clinical engineer got to the hospital on the same day for inspection.Service repair was performed by manufacturer representative on june 03, 2013.With a surgical back up team the old splice repair location was opened and it was clearly visible that the blue wire had been pulled out.Inspection of the driveline showed no further damage.The wire was inserted again.In discussion with the physician epoxy was used to secure the pins within the connector block.The pump was restarted in dual stator mode to clear e-fault.Flow and power returned to normal.The problem was solved without any reported patient injury.No further information is available.

• 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: 6039622
• MDR Text Key: 57815564
• Report Number: 3007042319-2016-03671
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 06/05/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2012
• Device Catalogue Number: 1104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/05/2013
• Initial Date FDA Received: 10/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1604-2015
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention