MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE MOBILE POWER UNIT, NA; VENTRICULAR (ASSIST) BYPASS

Model Number 107754

Device Problems Device Difficult to Setup or Prepare (1487); Electrical Power Problem (2925)

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

Event Date 06/03/2022

Event Type  malfunction  

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported events of a no external power alarm regarding the mobile power unit (mpu) and lower voltage values were confirmed via the provided log file.The log file contained data spanning approximately 9 days (25may2022 ¿ 03jun2022 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 throughout the data while connected to batteries or to the mpu; however, no atypical alarms were observed as a result of these lower values while the mpu was in use.A no external power alarm was observed on (b)(6) 2022 at 00:47 while the mpu was in use.The alarm appeared to have been caused by a loss of ac power, as the rsoc steadily decreased.The alarm resolved when power was restored to the system.The mpu (serial number (b)(4) was not returned for analysis.Per the reported event, the root cause of the no external power event was the mpu¿s power cord accidentally becoming disconnected from the wall outlet; however, the root cause of how the cable became disconnected was unable to be determined.The root cause of the below-average voltage values was unable to be determined through this analysis.Review of the device history record for the mobile power unit, serial number (b)(4), showed the device was manufactured in accordance with manufacturing and quality assurance specifications.The mpu was shipped to the customer on (b)(6) 2017.The heartmate ii patient handbook (rev.F, section 5 ¿alarms and troubleshooting¿) describes all alarms (visual and audible) and what action should be performed when they do occur, including the no external power alarm: to resolve the no external power alarm: 1.Immediately connect the system controller power cables to a working power source (functioning mobile power unit or two fully-charged heartmate 14 volt lithium-ion batteries).2.Call your hospital contact immediately if connecting to power does not resolve the alarm.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.

Event Description

It was reported that the patient had a no external power on (b)(6) 2022 that they said occurred when they accidentally pulled the cord out of the wall.Log files confirmed no external power events on (b)(6) 2022 while hooked up to wall power.Log files also revealed times when the voltage supplied to the controller was lower than expected.This occurred while the patient was on wall power.Related manufacturer report number 2916596-2022-11882.

• Brand Name: HEARTMATE MOBILE POWER UNIT, NA
• 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: 14841767
• MDR Text Key: 300805479
• Report Number: 2916596-2022-11604
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024010883
• UDI-Public: 813024010883
• 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: 06/28/2022

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 Model Number: 107754
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/03/2022
• Initial Date FDA Received: 06/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2017
• 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: 75 YR
• Patient Sex: Female
• Patient Weight: 72 KG