MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II SYSTEM CONTROLLER; VENTRICULAR (ASSIST) BYPASS

Model Number 106762

Device Problem Communication or Transmission Problem (2896)

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

Event Date 05/07/2019

Event Type  malfunction  

Event Description

It was reported that the patient's controller was noted to have no communication with the system monitor.The system monitor was rebooted without success.The site changed the system monitor and power module, but this did not resolve the issue.The system controller was exchanged.

Manufacturer Narrative

Manufacturer's investigation conclusion: incidental findings during the investigation found fluid ingress.The reported event of a communication issue with the system controller was confirmed.The heartmate ii system controller, serial (b)(4), returned without being able to communicate with the system monitor.The white cable jacket and shielding were stripped back revealing a detached orange transmission communication wire with fluid ingress in the cable.There damage was found at the start of the strain relief on the controller housing side.This wire was responsible for the lack of data transmission and so the power cables were replaced to continue testing.The controller was then functionally tested and found to operate as intended during analysis.No atypical alarms were produced during testing.The controller was able to support pump function for an extended period of time.The root cause for the reported communication issue was a severed orange communication wire in the white power cable.Device history records were reviewed and showed no deviations from manufacturing or qa specifications.The patient handbook cautions the users to call their hospital contacts if they think, for any reason, any portion of their equipment is not functioning as usual, is broken, or they are uncomfortable with the operation of the equipment.Heartmate ii instructions for use section 8-¿equipment storage and care¿ and heartmate ii patient handbook doc.Section 6-¿caring for the equipment¿ explain how to properly maintain the integrity of the system controller.The ifu states how to store, transport, and maintain the system controller to prevent damage such as tears and fluid ingress.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE II SYSTEM CONTROLLER
• Type of Device: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer Contact: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 15103621
• MDR Text Key: 304439629
• Report Number: 2916596-2022-12523
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024011286
• UDI-Public: 00813024011286
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P060040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2020
• Device Model Number: 106762
• Device Catalogue Number: 106762
• Device Lot Number: 6897136
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 93 KG