MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LVAS IMPLANT KIT; VENTRICULAR (ASSIST) BYPASS

Model Number 106524INT

Device Problem Pumping Stopped (1503)

Patient Problem Chest Pain (1776)

Event Date 07/10/2022

Event Type  Injury  

Event Description

It was reported that the patient fell asleep while on batteries the evening of (b)(6) 2022.The patient awoke with chest pain and proceeded to get up and replace the power sources as the pump was off and not attached to any working power sources.The patient was readmitted to the hospital and the pump stop and the pump appeared to be working well with no underlying issues.

Manufacturer Narrative

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

Manufacturer Narrative

Manufacturer's investigation conclusion: review of the submitted log files confirmed full depletion of the patient¿s 14 volt batteries and backup battery, which would have resulted in a pump stoppage for an undetermined amount of time.Additionally, a direct correlation between heartmate 3 left ventricular assist system (lvas), serial number (b)(6), and the reported chest pain could not be conclusively determined through this evaluation.The controller event log file contained data from (b)(6) 2022 through (b)(6) 2022, per the timestamps.Following this timeframe, the controller clock was corrupt until (b)(6) 2022 when the clock was manually adjusted.The log file captured low power advisory, low power hazard, and no external power alarms on (b)(6) 2022 associated with the depletion of the patient¿s 14 volt batteries.The backup battery began powering the system during the no external power events.The file then captured controller clock corrupt alarms when the patient reconnected to a fully charged battery, indicating that there was a total loss of power to the system which would have resulted in a pump stop.Of note, the duration of the pump stop could not conclusively be determined through this evaluation.The pump regained speed after being reconnected to power and functioned as intended at the set speed for the remaining duration of the file.No other notable events or alarms were captured.The patient remains ongoing on heartmate 3 lvas, serial number (b)(6), with no further issues reported at this time.The relevant sections of the device history records for (b)(6) reviewed and showed no deviations from manufacturing or quality assurance specification.The heartmate 3 left ventricular assist system (lvas) instructions for use (ifu), rev.C, is currently available.Section 1, ¿introduction¿, lists adverse events that may be associated with the use of the heartmate 3 lvas.Section 2, ¿system operations¿, states that the 11 volt lithium-ion backup battery should be used only for temporary support during a power-loss emergency.The 11 volt lithium-ion backup battery inside the heartmate 3 system controller provides enough power to run the implanted heartmate 3 pump for at least 15 minutes if the main power source (either the power module, mobile power unit, or two heartmate 14 volt lithium-ion batteries) is disconnected or fails.Inappropriate use of the 11 volt lithium-ion backup battery may result in diminished run time during a power-loss emergency.Additionally, every heartmate 14 volt lithium-ion battery also has its own on-battery gauge.It shows the power level for that battery.4 green bars = 75¿100% of battery power remains.3 green bars = 50¿75% of battery power remains.2 green bars = 25¿50% of battery power remains.1 green bar = less than 25% of battery power remains.Section 3, ¿powering the system¿, and section 6, ¿patient care and management¿, warn that the patient must always connect to the power module or mpu for sleeping or when there is a chance of sleep.A sleeping patient may not hear system controller alarms.These sections also warn not to use batteries to power the system when the patient is sleeping.Section 6 includes a section on ¿preparing for sleep¿, which details the steps patients should take when going to sleep.These steps include switching to the pm or mpu and states that if a patient falls asleep during battery-powered operating, the low battery alarms may not awaken the patient before battery depletion.Also, section 7, ¿alarms and troubleshooting¿, details all system controller alarms and how to resolve them.The heartmate 3 lvas patient handbook, rev.G, is also currently available.Section 5, ¿alarms and troubleshooting¿, provides information regarding system controller alarms and the proper actions associated with them.This section also includes detailed instructions on connecting and disconnecting to power under ¿guideline for power cable connectors.¿ section 3, ¿powering the system¿, details how to check a battery's charge level, replacing low batteries with fully-charged batteries, and switching power sources.Two, new, fully charged li-ion batteries provide 17 hours of support.Batteries last for less time if the user is active or emotionally stressed.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE 3 LVAS IMPLANT KIT
• 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: 15043081
• MDR Text Key: 296073531
• Report Number: 2916596-2022-12282
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/06/2022
• Device Model Number: 106524INT
• Device Lot Number: 7730323
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/11/2022
• Initial Date FDA Received: 07/18/2022
• Supplement Dates Manufacturer Received: 07/28/2022
• Supplement Dates FDA Received: 08/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2020
• 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 Outcome(s): Other; Hospitalization
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 105 KG