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

Model Number 106762

Device Problems Display Difficult to Read (1181); Display or Visual Feedback Problem (1184); Mechanical Problem (1384)

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

Event Date 11/12/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the patient got their system controller wet.The patient was unable to obtain readings from the led screen and was unable to perform a self-test by de-pressing the battery button.The patient walked into clinic for controller evaluation.The ventricular assist device (vad) coordinator was also unable to get the self-test feature to perform.Connecting to system monitor, no alarms were noted with appropriate settings and readings.A controller exchange was performed.

Manufacturer Narrative

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

Event Description

It was reported that the patient got their system controller wet.The patient was unable to obtain readings from the led screen and was unable to perform a self-test by de-pressing the battery button.The patient walked into clinic for controller evaluation.The ventricular assist device (vad) coordinator was also unable to get the self-test feature to perform.Connecting to system monitor, no alarms were noted with appropriate settings and readings.A controller exchange was performed.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of fluid ingress was able to be confirmed.The heartmate ii system controller (serial number: (b)(6)) was returned for analysis, and a log file was submitted for review.A review of the submitted log files showed events spanning approximately 4 days ((b)(6) 2001, (b)(6) 2021 ¿ (b)(6) 2021 per timestamp).Events captured on (b)(6) 2001 took place when the clock was not set; therefore, the exact date and times of the events were unable to be accurately recorded.The clock was set on (b)(6) 2021 at 12:36:21 and the driveline was connected on (b)(6) 2021 at 13:25:33.The driveline was disconnected on (b)(6) 2021 at 12:33:45 and the controller was shut off at 12:34:14.There were no notable alarms active pertaining to the reported event in the log file.Pump operation was not affected while the driveline was connected.The system controller underwent preliminary and functional testing and passed.Upon startup, lines and blank spots were found on the lcd display.The system controller was able to function as intended.The reported event of fluid ingress caused the damage to the lcd display and interior of the system controller; however, it did not affect the controller¿s capability to operate a pump.The root cause of the reported event was conclusively determined to be caused by fluid ingress.The device history records were reviewed for the system controller (serial number: (b)(6)) and was found to pass all manufacturing and qa specifications before being shipped to the customer on 07aug2020.Heartmate ii instructions for use section 8 entitled ¿equipment storage and care¿ and heartmate ii patient handbook section 6 entitled ¿caring for the equipment¿ addresses how to properly care for and maintain the equipment for proper use including how to ensure that the controllers and equipment do not get wet.Heartmate iii instructions for use section 7 entitled ¿alarms and troubleshooting¿ and heartmate iii patient handbook section 5 entitled ¿alarms and troubleshooting¿ addresses how to properly interpret and troubleshoot all system alarms including power cable disconnect alarm conditions, and the actions to take if the alarms cannot be resolved.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 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
• 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: 12916820
• MDR Text Key: 285855343
• Report Number: 2916596-2021-06900
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/27/2023
• Device Model Number: 106762
• Device Catalogue Number: 106762
• Device Lot Number: 7585282
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/27/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 106 KG