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

Model Number 1407DE

Device Problems No Display/Image (1183); Display or Visual Feedback Problem (1184); Poor Quality Image (1408); Power Problem (3010)

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

Event Date 07/23/2019

Event Type  malfunction  

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.Additional devices: heartware ventricular assist system ¿ battery, (b)(4) / model #: 1650, expiration date: 2019-07-31.Device available for eval: no.Device eval by mfr: no.Mfg date: 2018-07-20.Labeled for single use: no.(b)(4).Heartware ventricular assist system ¿ battery, (b)(4) / model #: 1650, expiration date: 2016-09-30.Device available for eval: no.Device eval by mfr: no.Mfg date: 2015-09-30.Labeled for single use: no.(b)(4).Heartware ventricular assist system ¿ battery, (b)(4) / model #: 1650, expiration date: 2016-09-30.Device available for eval: no.Device eval by mfr: no.Mfg date: 2015-09-30.Labeled for single use: no.(b)(4).Heartware ventricular assist system ¿ battery, (b)(4) / model #: 1650, expiration date: 2017-08-31.Device available for eval: no.Device eval by mfr: no.Mfg date: 2016-08-31.Labeled for single use: no.(b)(4).Heartware ventricular assist system ¿ battery, (b)(4) / model #: 1650, expiration date: 2017-07-31.Device available for eval: no.Device eval by mfr: no.Mfg date: 2016-07-31.Labeled for single use: no.(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the batteries experienced power switching.Patient was unable to verify which batteries were involved therefore all batteries were lubricated and remain in use.Controller beeped and indicator lights turned on and off.Controller was exchanged.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: one (1) controller and six (6) batteries were not returned for evaluation.Log file analysis revealed that the controller in use du ring the reported event contained a feature that records whether a power source experienced a communication error or a disconnection within each 15-minute interval.Analysis of the data log files revealed several premature power switching events due to momentary disconnections involving bat222167, bat221232, bat220554, bat208414, bat207941 as well as premature power switching events due to com munication errors involving bat220554.Data log files also revealed momentary disconnections that did not lead to power switching involving bat603588, bat221232, bat220554, bat208414, bat207941.Momentary disconnections will result in an audible tone or ¿beep.¿ when a battery momentarily disconnects, the indicator lights on the controller will turn off; upon the battery¿s reconnection, the ind icators will turn back on.As a result, the reported events were confirmed.A power source lubrication procedure was performed on battery bat222167 in accordance with the requirements on (b)(6) 2018 to mitigate the reported conditions.A power source lubrication procedure was performed on battery bat603588 in accordance with the requirements under on (b)(6) 2018 to mitigate the reported conditions.There is no evidence that the lubrication servicing was performed on batteries bat207941, bat208414, bat221232, bat220554 prior to the reported event.A power source lubrication procedure was performed on all associated devices in accordance with the requirements on (b)(6) 2019 to mitigate the reported conditions.While the product was not available for physical analysis, the most likely root cause of the reported premature power switching event can be attributed to communication errors between the controller and battery and/or due to momentary disconnections between the controller and batteries due to corrosion of the controller power port pins.However, the most likely root cause of the reported ¿beeps¿ and display error can be attributed to momentary disconnections between the controller and batteries due to corrosion of the controller power port pins.Internal investigation was done for momentary disconnections prior to lubrication servicing.Additional devices: d1: heartware ventricular assist system ¿battery d4: bat603588/ model #: 1650 h6: fdm (s): 4112, 4114 h6: fdr (s): 3212 h6: fda conclusion code(s): 4307 d1: heartware ventricular assist system ¿battery d4: bat207941/ model #: 1650 h6: fdm (s): 4112, 4114 h6: fdr (s): 3212 h6: fda conclusion code(s): 12 d1: heartware ventricular assist system ¿battery d4: bat2081414/ model #: 1650 h6: fdm (s): 4112, 4114 h6: fdr (s): 3212 h6: fda conclusion code(s): 12 d1: heartware ventricular assist system ¿battery d4: bat221232/ model #: 1650 expiration date: 2017-07-31 d10: no h3: no h4: mfg date: 2016-07-31 h5: no h6: patient code(s): 2692 h6: device code(s): 2885 h6: fdm (s): 4112, 4114 h6: fdr (s): 3212 h6: fda conclusion code(s): 12 d1: heartware ventricular assist system ¿battery d4: bat222167/ model #: 1650 h6: fdm (s): 4112, 4114 h6: fdr (s): 3212 h6: fda conclusion code(s): 4307 d1: heartware ventricular assist system ¿battery d4: bat220554/ model #: 1650 h6: fdm (s): 4112, 4114 h6: fdr (s): 3212 h6: fda conclusion code(s): 12, 4307 medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.If information is provided in the future, a supplemental report will be issued.

• Brand Name: HEARTWARE® VENTRICULAR ASSIST SYSTEM-CONTROLLER
• Type of Device: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 8871956
• MDR Text Key: 204947281
• Report Number: 3007042319-2019-09012
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 09/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2015
• Device Model Number: 1407DE
• Device Catalogue Number: 1407DE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2019
• Date Manufacturer Received: 09/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1903-2018
• Patient Sequence Number: 1
• Patient Age: 74 YR