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

Model Number L107758

Device Problems Crack (1135); Loose or Intermittent Connection (1371); Mechanical Problem (1384)

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

Event Date 04/28/2022

Event Type  malfunction  

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.

Event Description

It was reported the mobile power unit (mpu) patient cable was loose near the connectors.Additionally, the battery door was cracked.

Manufacturer Narrative

Section d4: expiration date was inadvertently included in the initial report and is not applicable for this device manufacturer's investigation conclusion: the reported events of issues with the patient cable connector and damage on the battery compartment cover were confirmed via evaluation of the returned mobile power unit (mpu) (serial number: (b)(6)).The mpu was evaluated at european distribution center (edc) and manipulation of the patient cable rubber encasing revealed that it was loose due to a gap being observed between the plastic lemo connectors and the rubber.Further inspection revealed that the battery compartment cover was slightly cracked near the locking screw.The mpu was connected to a mock circulatory loop and operated without any issues observed or alarms active.The damage observed did not affect the functionality of the unit.The mpu was then functionally tested and the unit passed without any issues.The mpu was then returned to the rental pool.The root cause of the reported events could not be conclusively determined through this analysis.The device history records were reviewed and the records revealed that the mobile power unit, serial number (b)(6), was manufactured in accordance with manufacturing and qa specifications.The mobile power unit was shipped to the customer on (b)(6) 2016.Heartmate 3 instructions for use (ifu) (rev.G) section 8, entitled ¿equipment storage and care¿, and heartmate 3 patient handbook (rev.G) section 6, entitled ¿caring for equipment¿, explain how to properly care for the equipment, including the mpu and the patient cable.Heartmate 3 patient handbook (rev.G) section 10, entitled ¿safety checklists¿, provides checklists to assist the patient in performing routine maintenance of heartmate 3 lvad, including inspecting the mpu and the mpu patient cable connectors for damage.This section also informs the user to replace any equipment or system component that appears damaged or worn.The heartmate 3 patient handbook (rev.G) cautions the user 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: 14270066
• MDR Text Key: 290775519
• Report Number: 2916596-2022-10725
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 05/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2022
• 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: 8429591
• 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: 05/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/25/2016
• 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