MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 SYSTEM CONTROLLER; VENTRICULAR (ASSIST) BYPASS

Model Number 106531US

Device Problems Fluid/Blood Leak (1250); Mechanical Problem (1384)

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

Event Date 05/26/2022

Event Type  malfunction  

Event Description

It was reported that the patient had a small slit in the white battery attachment cable on their controller.Log files did not show any aberrations and patient had very frequent pulsatility index (pi) events which is normal for the patient.The slit was oozing bright green "goo", which was never encountered before.When the goo was wiped away, more oozing occurred.The controller was exchanged and the patient tolerated the exchange well.

Manufacturer Narrative

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

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of fluid ingress inside a cut on the white power cable was confirmed.Visual inspection of the returned hm3 system controller, serial (b)(6), revealed a cut on the silicone jacket of the white power cable with evidence of fluid ingress.The controller was functionally tested and operated on a mock circulatory loop for an extended period of time without any issue.The controller functioned as intended during analysis.A root cause of the reported event was not determined through this analysis.There was incidental finding of controller white power cable having a slightly higher than normal resistance.Device history records were reviewed and showed no deviations from manufacturing or qa specifications.The patient handbook cautions the 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.Heartmate iii instructions for use section 1 entitled ¿introduction¿ states that ¿if heartmate 3 patient are approved for showering, they must always use the shower bag.When installed properly, the shower bag protected external system components from water or moisture.If external system components have contact with water or moisture, the pump may stop¿.Heartmate iii patient handbook section 4 entitled ¿living with the heartmate 3¿ provides proper instruction on how to properly shower with the heartmate 3 system.Heartmate iii instructions for use section 8-¿equipment storage and care¿ and heartmate iii patient handbook section 6-¿caring for the equipment¿ explain how to properly maintain the integrity of the system controller.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE 3 SYSTEM CONTROLLER
• 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: 14631838
• MDR Text Key: 293638154
• Report Number: 2916596-2022-11339
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013235
• UDI-Public: 00813024013235
• 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: 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: 06/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/08/2022
• Device Model Number: 106531US
• Device Catalogue Number: 106531US
• Device Lot Number: 7174869
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2019
• 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: 41 YR
• Patient Sex: Male
• Patient Weight: 115 KG
• Patient Ethnicity: Hispanic