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

Model Number 107754

Device Problems Mechanical Problem (1384); Complete Loss of Power (4015)

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

Event Date 07/06/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that every time the patient was tethered to their mobile power unit (mpu), a no external power alarm occurred.An inspection of the mpu revealed cuts on the ac power cord.The ac power cord did not have a v-lock connector.It was unknown if the ac power cord came loose, and there were no environmental circumstances that could have affected ac power.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of no external power alarms when connected to the mobile power unit (mpu) was confirmed.The mpu (serial number: (b)(6) was returned to service depot for evaluation, and the reported event was reproduced during testing with a test system controller on a mock circulatory loop.No other issues were observed during testing on the mock circulatory loop.Visual inspection of the returned mpu revealed several cuts on the patient cable.The customer was provided with a quote for repair multiple times; however, the customer did not provide approval for repairs.The mpu was not repaired and no further testing was performed.The mpu is not certified for use and will be returned to the customer unrepaired.The root cause of the reported event could not be conclusively determined through this analysis; however, the damaged patient cable may have contributed to the reported event.Device history records were reviewed and showed no deviations from manufacturing or quality assurance (qa) specifications.The mobile power unit, serial number (b)(6), was shipped to the customer on 06nov2021.Heartmate 3 patient handbook (rev.D), under section 5 ¿alarms and troubleshooting¿ and heartmate 3 instructions for use (ifu) (rev.C), under section 7 ¿alarms and troubleshooting¿, cover all alarms (visual and audible), including the no external power alarm, and the actions to take if the alarms cannot be resolved.Furthermore, the subsection ¿what not to do: driveline and cables¿ informs the user to check the system controller power cables for twisting, kinking, or bending which could cause damage to the wires inside.This section informs the user not to ¿twist, kink, or sharply bend the mobile power unit patient cable¿ and states ¿if the driveline or cables become twisted, kinked, or bent, carefully unravel and straighten¿.Heartmate 3 patient handbook (rev.D) section 6 "caring for the equipment" and heartmate 3 ifu (rev.C) section 8 ¿equipment storage and care¿ describe how to care for and clean all equipment.Heartmate 3 patient handbook (rev.D) section 10 and heartmate 3 ifu (rev.C) section f, both entitled ¿safety checklists¿, provide checklists to assist the patient in performing routine maintenance of heartmate 3 lvad.This section also informs the user to replace any equipment or system component that appears damaged or worn.Heartmate 3 patient handbook (rev.D) 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 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: 15134893
• MDR Text Key: 304447719
• Report Number: 2916596-2022-12324
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024010883
• UDI-Public: 00813024010883
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 107754
• Device Catalogue Number: 107754
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/2021
• 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: 63 YR
• Patient Sex: Male
• Patient Weight: 69 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White