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

Model Number 106531US

Device Problems No Display/Image (1183); Display or Visual Feedback Problem (1184)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/01/2020

Event Type  malfunction  

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

It was reported that the patient's controller screen was "whited out", and would not show data from the pump.A self-test was performed and the pump was on, and functioning, and no alarms were occurring.The screen then returned to the "whited out" state following the self-test.Per a representative, there is believed to be a glitch with the led screen.A controller exchange was performed on 01oct2020.The were no patient consequences.Additional information received on 12oct2020 confirmed that the controller screen was completely unreadable.

Manufacturer Narrative

Section h3 and h6: additional information manufacturer's investigation conclusion: the reported event of a blank white display was confirmed.The system controller was opened, and the lcd was replaced with a test lcd.The blank white display was resolved.The system controller was connected to the mock loop and was able to operate nominally.The system controller underwent preliminary and functional testing and passed.The root cause for the reported event was conclusively determined to be due to an issue with the lcd.The device history records were reviewed and the records revealed that the heartmate iii system controller was manufactured in accordance with manufacturing and qa specifications.Heartmate iii instructions for use section 8 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 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 no further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE 3 SYSTEM CONTROLLER
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 10698125
• MDR Text Key: 211953319
• Report Number: 2916596-2020-04968
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013235
• UDI-Public: 00813024013235
• Combination Product (y/n): N
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 11/30/2020

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/22/2022
• Device Model Number: 106531US
• Device Catalogue Number: 106531US
• Device Lot Number: 7184224
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/01/2020
• Initial Date FDA Received: 10/19/2020
• Supplement Dates Manufacturer Received: 11/25/2020
• Supplement Dates FDA Received: 11/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 33 YR
• Patient Weight: 130