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

Model Number L107758

Device Problems Material Discolored (1170); Mechanical Problem (1384); Detachment of Device or Device Component (2907)

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

Event Date 10/19/2021

Event Type  malfunction  

Event Description

It was reported the mobile power unit patient cable was heavily discolored and was loose around the rubber end at the black and white connectors.

Manufacturer Narrative

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

Manufacturer Narrative

Incidental findings: damaged housing and screw on mobile power unit.Manufacturer's investigation conclusion: the reported event of a heavily discolored patient cable and a loose rubber end at the black and white connector was confirmed via the returned mobile power unit (mpu).The mpu (serial number (b)(6)) was returned and evaluated at the european distribution center (edc) on (b)(6) 2021.The mpu was observed at the edc and the rubber encasing of the patient cable was observed to be loose.Additionally, the patient cable was observed to be discolored.The system was functionally tested and passed all steps without issue.The patient cable replaced, preventative maintenance was performed on the device, and the patient cable was forwarded to product performance engineering (ppe) for analysis.The loose rubber encasing on the patient cable and the discolored cable was confirmed during ppe testing.Additionally, the patient cable was placed in a known working test unit and functioned as intended.The root cause of the reported event could not be determined through this analysis.The device history records were reviewed and the records revealed the heartmate mobile power unit (serial#: (b)(6)) was manufactured in accordance with manufacturing and qa specifications.Heartmate 3 instructions for use section 8 ¿ ¿equipment storage and care¿ and heartmate 3 patient handbook section 6 ¿ ¿caring for equipment¿ explain how to properly care for the equipment, including the mpu patient cable.Heartmate 3 patient handbook section 6 ¿ "caring for the equipment" describes how to care for and clean all equipment, including the mpu patient cable.Section 10, entitled ¿safety checklists¿, provides 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.The patient handbook and the instructions for use caution 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: 12795624
• MDR Text Key: 281905596
• Report Number: 2916596-2021-06339
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 01/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2021
• 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: 5468353
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/17/2015
• 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