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

Model Number L107758

Device Problems Crack (1135); Mechanical Problem (1384)

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

Event Date 02/21/2022

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 that the mobile power unit (mpu) had damage on the bottom cover near the patient cable inlet and ac power inlet.There was also damage on an inner corner and near the "screw holders" of the main board.The battery latch was also cracked near the screw.The system otherwise functioned as intended.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of damage on the bottom housing and battery compartment cover of the mobile power unit (mpu) was confirmed via evaluation of the returned mpu serial number: (b)(6).The returned mpu was evaluated at the european distribution center (edc).Visual inspection of the unit revealed multiple cracks on the bottom housing near the patient cable inlet and near the ac power cord inlet.Further inspection revealed that a screw holder in a corner of the unit¿s interior was almost detached from the bottom housing and that the battery compartment cover was slightly cracked near the locking screw.The bottom housing and the battery compartment cover were replaced.The mpu was then functionally tested and passed without issue.The root cause of the reported event 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 08jul2016.Heartmate 3 instructions for use (ifu) section 8, entitled ¿equipment storage and care¿, and heartmate 3 patient handbook 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 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 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 (ASSISST) 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: 13593734
• MDR Text Key: 289278545
• Report Number: 2916596-2022-01191
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/10/2022

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: L107758
• Device Lot Number: 176044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/21/2022
• Initial Date FDA Received: 02/24/2022
• Supplement Dates Manufacturer Received: 02/25/2022
• Supplement Dates FDA Received: 03/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2016
• 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