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

Model Number 106762

Device Problems Degraded (1153); Mechanical Problem (1384); Low Readings (2460)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/30/2020

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

Related manufacturer¿s report #2916596-2020-03453.It was reported that the patient had low speed limits after a controller exchange and rescue tape on his driveline.After an equipment check the patient's primary controller was found to need replacement due to the bend relief damage and the screen discoloration.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported events of bend relief damage and discoloration of the lcd screen were confirmed via evaluation of the returned system controller (serial number: (b)(6).Visual inspection of the returned system controller revealed that the black and white power cable strain reliefs on the connector side were broken.A green discoloration of the lcd display consistent with fluid ingress was also observed when the controller was connected to a test power module/system monitor.The system controller was disassembled for further inspection and fluid ingress was observed on the internal components, including the lcd screen and lcd printed circuit board (pcb).The damaged strain reliefs and fluid ingress did not affect the functionality of the controller during testing.The controller successfully operated in a mock circulatory loop for an extended period of time without any issues or atypical alarms produced.The log file downloaded from the returned controller contained approximately 6 days of data (b)(6) 2020 per the timestamp).The driveline was disconnected on (b)(6) 2020 at 10:07:27 to exchange the system controller.The pump maintained a speed above the low speed limit throughout the log file while the driveline was connected.The root cause of the reported bend relief damage could not be conclusively determined through this analysis.The reported discoloration of the lcd display was determined to be caused fluid ingress inside the system controller; however, the root cause of the fluid ingress could not be conclusively determined through this analysis.During the investigation the following incidental findings were observed: pin stuck in socket 8 (shield) of the black power cable connector, dim pump running leds, serial number worn off of the label.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE II SYSTEM CONTROLLER
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 10307322
• MDR Text Key: 202618136
• Report Number: 2916596-2020-03667
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024011286
• UDI-Public: 00813024011286
• Combination Product (y/n): N
• PMA/PMN Number: P060040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 12/09/2020

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: Health Professional
• Device Expiration Date: 05/31/2020
• Device Model Number: 106762
• Device Catalogue Number: 106762
• Device Lot Number: 6299175
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/30/2020
• Initial Date FDA Received: 07/22/2020
• Supplement Dates Manufacturer Received: 09/18/2020; 09/18/2020
• Supplement Dates FDA Received: 10/15/2020; 12/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS)
• Patient Age: 52 YR
• Patient Weight: 124