MAUDE Adverse Event Report: HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY; VENTRICULAR (ASSIST) BYPASS

Model Number	1650
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product event summary: six batteries were not returned for evaluation.Log file analysis was not conducted since log files covering the event date were not available.As a result, the reported event could not be confirmed.A power source lubrication procedure was performed on the associated batteries on (b)(6) 2018.Applicable risk documentation and experience with events of similar circumstances were considered; a possible root cause of the reported premature power switching event after lubrication can be attributed, but not limited to a communication error and/or to momentary disconnection due to corrosion of the controller power port pins.Events involving panasonic batteries that rapidly discharge can be attributed to soldering or welding defects.Serial or lot#: (b)(4).Serial or lot#: (b)(4).Serial or lot#: (b)(4).If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
This device is used for treatment not diagnosis.The ventricular assist system is indicated for use as a bridge to cardiac transplantation and destination therapy 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.Concomitant medical products: c2tr01 pacemaker, 5076-52 lead, 5076-45 lead, 419688 lead, implanted: (b)(6) 2011.Additional products: heartware ventricular assist system ¿ battery.Model #: 1650 / catalog #: 1650 / expiration date: 31-aug-2017 / serial or lot#: (b)(4).Udi #: (b)(4).Device available for eval: no.Mfg date: 31-aug-2016.Label for single use: no.(b)(4).Heartware ventricular assist system ¿ battery.Model #: 1650 / catalog #: 1650 / expiration date: 30-nov-2017 / serial or lot#: (b)(4).Udi #: (b)(4).Device available for eval: no.Mfg date: 30-nov-2016.Labeled for single use: no.(b)(4).Heartware ventricular assist system ¿ battery.Model #: 1650 / catalog #: 1650 / expiration date: 30-nov-2017 / serial or lot#: (b)(4).Udi #: (b)(4).Device available for eval: no.Mfg date: 30-nov-2016.Labeled for single use: no.(b)(4).Heartware ventricular assist system ¿ battery.Model #: 1650 / catalog #: 1650 / expiration date: 30-jun-2017 / serial or lot#: (b)(4).Udi #: (b)(4).Device eval for eval: no.Mfg date: 30-jun-2016.Labeled for single use: no.(b)(4).Heartware ventricular assist system ¿ battery d4: model #: 1650 / catalog #: 1650 / expiration date: 30-nov-2017 / serial or lot#: (b)(4).Udi #: (b)(4).Device eval for eval: no.Mfg date: 30-nov-2016.Labeled for single use: no.(b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the batteries were draining quicker than normal, dropping bars, and switching to the other side.The patient stated that fully charged batteries were being plugged in to the controller and within one to two hours they were dropping down to one bar.The batteries were exchanged.No patient complications have been reported as a result of this event.

• Brand Name: HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY
• Common Device Name: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 8993050
• Report Number: 3007042319-2019-10846
• Device Sequence Number: 14175956
• Product Code: DSQ
• UDI-Device Identifier: 00888707000376
• UDI-Public: 00888707000376
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P100047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/30/2017
• Device Model Number: 1650
• Device Catalogue Number: 1650
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/21/2019
• Supplement Date Received by Manufacturer: 10/11/2019
• Initial Report FDA Received Date: 09/11/2019
• Supplement Report FDA Received Date: 10/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Weight: 56