MAUDE Adverse Event Report: HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0; VENTRICULAR (ASSISST) BYPASS

Model Number 1420

Device Problem Contamination (1120)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/15/2022

Event Type  malfunction  

Manufacturer Narrative

An initial report is being submitted for device analysis.Product event summary: the controller (con403658) was returned for evaluation.No performance allegations were made against the controller.Various analyses were conducted and reviewed in order to evaluate the performance of the device.Failure analysis revealed that the returned controller passed functional testing.Visual inspection revealed contamination within both power ports.Log file analysis revealed four (4) controller power up events logged on 27-jul-2022 at 20:40:16 and on 28-jul-2022 at 14:12:06, 14:12:39 and 14:24:30.Review of the event log file revealed that, prior to the first power up event, the controller last had power on 02-jun-2021, indicating that the power up event occurred during a controller exchange.The data point prior to the controller power up event logged on 28-jul-2022 at 14:12:39 revealed that an adapter was connected to power port one (1) and power port two (2).The data point recorded after the loss of power revealed that an active adapter was connected to power port one (1) and (b)(4) was connected to power port two (2).The controller was without power for a maximum of 33 seconds.The data point prior to the loss of power logged on 28-jul-2022 at 14:24:30 revealed that an active adapter was connected to power port one (1) and (b)(4) was connected to power port two (2).The data point recorded after the loss of power revealed that (b)(4) was connected to power port one (1) and (b)(4) was connected to power port two (2).The controller was without power for 29 seconds.Based on the available information, the most likely root cause of the initial power up events can be attributed to a controller exchange.A possible root cause of the remaining of power events can be attributed to a disconnection of both power sources and/or to an intermittent disconnection on one or both power sources.Capa pr(b)(4).Is investigating controller losses of power.The most likely root cause of the observed contamination can be attributed to the handling of the device.Investigation of this event is completed and the file will be closed.If new information is received, the file will be re-opened and a supplemental will be submitted.If information is provided in the future, a supplemental report will be issued.

Event Description

A controller was returned to the manufacturer and subsequently tested out of specification during manufacturer¿s analysis.No patient complications have been reported as a result of this event.

• Brand Name: HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• Manufacturer (Section G): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 15531611
• MDR Text Key: 301766249
• Report Number: 3007042319-2022-07893
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2019
• Device Model Number: 1420
• Device Catalogue Number: 1420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2022
• Date Manufacturer Received: 09/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/17/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Sex: Male
• Patient Weight: 126 KG