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

Model Number	1430US
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/23/2019
Type of Reportable Event	Malfunction
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.Product event summary: two controller ac adapters ((b)(4)) were returned for evaluation.The controller ac adapters were returned without power cords.Various analyses were conducted and reviewed in order to evaluate the performance of the returned devices in relation to the reported event.Failure analysis of the returned devices revealed that units passed visual inspection and functional testing.A review of the packaging documentation revealed that the power cords were not packaged with the associated controller ac adapters.As a result the reported event was confirmed.A possible root cause of the reported event can be attributed to packaging issues.An internal investigation was initiated to evaluate this issue.Additional products: heartware ventricular assist system ¿ controller ac adapter, model #: 1430us / catalog #: 1430us / expiration date: 30-sep-2021 / serial #: (b)(4), udi #: (b)(4).Device available for evaluation: yes, return date: 08-jan-2020.Device evaluated by mfr: yes dev rtn to mfr? yes.Mfg date: 01-oct-2019.Labeled for single use: no.(b)(4).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 or Problem Description
Two controller ac adapters were returned to the manufacturer because they were received and the shipments did not include power cords.The controller ac adapters subsequently tested out of specification during manufacturer's analysis.There was no patient involvement.

• Brand Name: HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER AC ADAPTER
• Common Device Name: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 10043744
• Report Number: 3007042319-2020-03135
• Device Sequence Number: 11378622
• Product Code: DSQ
• UDI-Device Identifier: 00888707006866
• UDI-Public: 00888707006866
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/11/2020

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: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: 1430US
• Device Catalogue Number: 1430US
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2020
• Initial Report FDA Received Date: 05/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1