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

Model Number 106762

Device Problems Mechanical Problem (1384); Material Deformation (2976)

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

Event Date 06/06/2022

Event Type  malfunction  

Event Description

It was reported that the patient presented to the emergency department (ed) with the silicone jacket on the black cable separated from the bend relief.A green slimy material was noted oozing out from under the silicone.It was noted that the patient had placed a significant amount of tape on the driveline due to tears in the silicone sheath.The patient had known phase to phase of their driveline.Log files captured driveline faults throughout the event history, indicating the green wire may be broken.A controller exchange was to be performed.Related manufacturer report number: 2916596-2022-11575.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported events of the system controller¿s black cable being damaged, revealing a green, fluid-like substance, were confirmed, as the returned system controller (serial number pcx-10037) was observed to have part of its black cable¿s jacket missing, revealing green fluid around the inner layer.The provided log file, as well as a log file extracted from the controller during testing, were reviewed, collectively containing data spanning approximately 23 days (14may2022 ¿ 07jun2022 per timestamp).The pump maintained speeds above the low speed limit while connected to the driveline.The patient¿s voltage values were observed to be below average while either batteries or wall power was in use.The returned system controller was functionally tested and was found to have increased resistances within its power cables, consistent with the observed lower voltage values within the log files.Despite the observed damage, the controller was able to operate a mock loop as intended throughout all testing.The controller¿s power cables were opened, and hardened dark green fluid was observed within the cables.The green liquid substance is the result of accumulated moisture underneath the permeable outer grey insulation that reacted with the underlying shielding/construction.The root causes of the reported events were unable to be conclusively determined through this analysis; however, the observed damage to the black cable could have allowed fluid to accumulate within the power cable assembly.Review of the device history record for system controller, serial number pcx-10037, showed the device was manufactured in accordance with manufacturing and quality assurance specifications.The controller was shipped to the customer on 20mar2017.The heartmate ii patient handbook (rev.F) instructs users to never submerge their equipment, including their system controller, underwater.The patient handbook also instructs users to never expose their equipment to liquids or fluids of any kind.The heartmate ii patient handbook (rev.F, section 10 ¿safety checklists¿) instructs users to regularly inspect their equipment for damage, including damage to the system controller¿s power cords, and to obtain replacements if needed.The heartmate ii patient handbook (rev.F, section titled ¿emergency contact list¿) cautions 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 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: 14791406
• MDR Text Key: 302500958
• Report Number: 2916596-2022-11574
• 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: 06/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2020
• Device Model Number: 106762
• Device Catalogue Number: 106762
• Device Lot Number: 5910012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/10/2017
• 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: 69 YR
• Patient Sex: Male
• Patient Weight: 112 KG