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

Catalog Number 1104

Device Problems Electrical /Electronic Property Problem (1198); Pumping Stopped (1503); Cut In Material (2454)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/28/2017

Event Type  Injury  

Manufacturer Narrative

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 hvad driveline is a cable that connects to the implanted pump and passes through the skin to connect to the external lvad system components.The instructions for use (ifu) and patient manual caution the user to not pull, kink or twist the driveline or the power cables, as these may damage the driveline.Special care should be taken not to twist the driveline while sitting, getting out of bed, adjusting the controller or power sources or when using the shower bag.Users are to examine the driveline for evidence of tears, punctures or breakdown of any of the material during exit site dressing changes.The ifu and patient manual also cautions users that they should not attempt to repair or service any heartware equipment.If service is required, they should contact their doctor, nurse or vad coordinator.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 the patient accidentally cut his driveline cable with a pair of scissors, resulting in a pump stop.The hospital technician performed a temporary repair using luster clamps on (b)(6) 2017 and the pump restarted.A driveline splice repair was successfully performed by heartware employee on (b)(6) 2017.There were no reported consequences or impact to the patient.

Manufacturer Narrative

Additional information received indicated that the driveline cable was cut into two.The patient was admitted to the hospital on (b)(6) 2017.The site temporarily repaired the driveline and the pump restarted on both motors.The pump had been off for approximately two hours.The driveline splice repair was performed in the intensive care unit (icu) on (b)(6) 2017.Pump was stopped during the procedure for approximately one minute.The patient was reportedly stable during pump off time.The patient was discharged on (b)(6) 2017.Controller log files, photos, and service report form were sent.Preliminary log file analysis revealed 1 vad disconnect alarm, 1 vad stopped alarm, 1 electrical fault alarm, and 1 controller power-up and associated pump start event on (b)(6) 2017.Heartware will submit a supplemental report when new facts arises which materially alters information submitted in a previous mdr report.

Manufacturer Narrative

Serial #: (b)(4) - controller / catalog number 1407de / expiration date: 31-oct-2017.Device available for evaluation: no.Device evaluated by mfr: no, other - device retained by patient.Labeled for single use: no.(b)(4).Heartware will submit a supplemental report when new facts arise which materially alters information submitted in a previous mdr report.

Manufacturer Narrative

Product event summary: the driveline and controller were not returned for evaluation.A review of the manufacturing documentation confirmed that the associated devices met all requirements for release.Log file analysis revealed a vad stopped and electrical fault alarm on (b)(6) 2017 at 18:45:16; an electrical fault alarm was logged due to an overcurrent trip in the front stator, causing the pump to stop (vad stopped alarm).A vad disconnect was logged a second later, at 18:45:17.A controller power up and motor start event was recorded at 20:28:09 and 20:28:13, respectively.A review of the data file revealed that the driveline was disconnected starting at 18:45:16 (vad stopped alarm) to 20:28:13, when the motor start event was recorded.The controller power up and motor start event was most likely due to the reported repair the site performed.Pump off time was approximately two (2) hours.Log file findings are consistent with damaged driveline cables.An on-site inspection on (b)(6) 2017 revealed that the driveline was completely cut, confirming the reported event.A driveline splice procedure was performed to mitigate the reported conditions.As a result, there is no evidence to suggest that a device malfunction caused or contributed to the reported event.The most likely root cause of the reported damage is an accidental cut of the driveline by the patient.Possible clinical factors that may have contributed to this event include the patient¿s pre-existing history and related comorbidities, the progression of their underlying disease, issues related to the therapeutic use of anticoagulant and antiplatelet medications and the patient's complex post-operative course.There are possible patient, pharmacological and procedural factors that may have contributed to this event.Additional products: controller 1.0, (b)(4) udi#: asku, returned to mfr: yes, mfg date: 2016-10-31.If information is provided in the future, a supplemental report will be issued.

• Brand Name: HEARTWARE® VENTRICULAR ASSIST SYSTEM - PUMP
• Type of Device: CIRCULATORY ASSIST SYSTEM,
• Manufacturer (Section D): HEARTWARE, INC; 14400 nw 60th avenue; miami lakes FL 33014 3105
• MDR Report Key: 6516244
• MDR Text Key: 73511955
• Report Number: 3007042319-2017-01248
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• PMA/PMN Number: P100047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2018
• Device Catalogue Number: 1104
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 59 YR
• Patient Weight: 80