MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 SYSTEM CONTROLLER; VENTRICULAR (ASSIST) BYPASS

Model Number 106531US

Device Problem Display Difficult to Read (1181)

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

Event Date 05/06/2022

Event Type  malfunction  

Manufacturer Narrative

Manufacturer's investigation conclusion: the device history records were reviewed for the system controller (serial number: (b)(4)) and was found to pass all manufacturing and qa specifications before being shipped to the customer on 15sep2020.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 iii instructions for use entitled ¿equipment storage and care¿ and heartmate iii patient handbook section 6 entitled ¿equipment maintenance¿ addresses how to properly care for, maintain, and store the equipment for proper use.The report that the patient's heartmate 3 (hm3) screen had discoloration was confirmed via the photo submitted to this complaint.The system controller lcd screen was discolored, and green was consistent with fluid ingress into the controller; the green discoloration did not prevent the parameters from being displayed or legible.The system controller (serial #: (b)(4)) was not returned for analysis.Provided information indicated that the controller was not exchanged.The discoloration of the lcd does not appear to be affecting the controller/pump operation.At this time, the tech service recommends monitoring the discoloration.If the discoloration worsens and starts to interfere with the display readings or unusual alarms are seen, the controller should be replaced.To date, the system controller (serial #: (b)(4) will not be returned for analysis.As a result, this complaint file will be closed with no further action.If the product is returned at a later time, the complaint file will be re-opened.No further information was provided.The manufacturer is closing the file on this event.

Event Description

It was reported that the patient's heartmate 3 (hm3) screen had discoloration.There were no alarms during this event.The log file review only showed routine pulsatility index (pi) events.The screen discoloration did not affect pump operation.

• Brand Name: HEARTMATE 3 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: 14657350
• MDR Text Key: 295435669
• Report Number: 2916596-2022-11586
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013235
• UDI-Public: 00813024013235
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160054
• 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: 06/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/12/2023
• Device Model Number: 106531US
• Device Catalogue Number: 106531US
• Device Lot Number: 7601632
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/12/2020
• 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: 58 YR
• Patient Sex: Male
• Patient Weight: 115 KG