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

Model Number L107758

Device Problems Material Discolored (1170); Mechanical Problem (1384)

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

Event Date 06/13/2022

Event Type  malfunction  

Event Description

It was reported that the mobile power unit (mpu) patient cable was discoloured and loose around the black and white connector.Additionally, the battery door and top handle were damaged.

Manufacturer Narrative

There was no patient involved in this event.The pma provided is associated with the device¿s most recent approval.No further information was provided.A supplemental report will be submitted once the manufacturer's investigation is complete.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of the rubber casing on the patient cable being loose around the black and white lemo connectors, discoloration of the patient cable, damage to the battery cover, and damage to the handle was confirmed.The returned mobile power unit (mpu), serial number (b)(6), was evaluated at the european distribution center (edc) and reported event was confirmed via visual inspection of the returned unit.The mpu was functionally tested and found to function as intended during analysis.The patient cable, battery cover, and handle were replaced.A full functional checkout was performed and the unit passed all tests.The root cause of the reported event could not be conclusively determined through this analysis.Device history records were reviewed and showed no deviations from manufacturing or qa specifications.(b)(6) was shipped to the customer on 18nov2019.Heartmate 3 instructions for use (rev.G) section 8 ¿ ¿equipment storage and care¿ and heartmate 3 patient handbook (rev.G) section 6 ¿ ¿caring for equipment¿ explain how to properly care for the equipment, including the mobile power unit (mpu).Heartmate 3 patient handbook (rev.G) and section 10 and heartmate 3 instructions for use (rev.G) section f, both entitled ¿safety checklists¿, provide checklists to assist the patient in performing routine maintenance of heartmate 3 lvad, including inspecting the mpu patient cable for damage.This section also informs the user to replace any equipment or system component that appears damaged or worn.Heartmate 3 patient handbook (rev.G) 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, EU
• 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: 14700510
• MDR Text Key: 297165067
• Report Number: 2916596-2022-11730
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: L107758
• Device Lot Number: 6375243
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2018
• 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