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

Model Number	1440
Medical Device Problem Codes	Misassembled (1398); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The controller dc adapter was returned to the manufacturer because it was unassembled when the box was opened.The controller dc adapter subsequently tested out of specification during manufacturer¿s analysis.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary: the controller dc adapter ((b)(4)) was returned for evaluation.A review of the manufacturing documentation confirmed that the associated device met all requirements for release.Various analyses were conducted and reviewed in order to evaluate the performance of the device in relation to the reported event.Failure analysis of the returned device, as well as visual evidence provided by the site, revealed that the adapter's plug components were present, but were not assembled.This observation did not allow the adapter to provide power.After the components were reassembled, the adapter performed as intended.As a result, the reported event was confirmed.The most likely root cause of the reported event can be attributed, but not limited, to an improper assembly.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.

• Brand Name: HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER DC ADAPTER
• Common Device Name: 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: 12920653
• Report Number: 3007042319-2021-08252
• Device Sequence Number: 17460731
• Product Code: DSQ
• UDI-Device Identifier: 00888707006880
• UDI-Public: 00888707006880
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P100047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/02/2021

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: 07/31/2022
• Device Model Number: 1440
• Device Catalogue Number: 1440
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2021
• Initial Report FDA Received Date: 12/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 1104 VAD
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 63 KG