MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA 70CC TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T); BIVENTRICULAR REPLACEMENT DEVICE

Model Number 500101-001

Device Problems Material Discolored (1170); Material Too Rigid or Stiff (1544)

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

Event Date 11/13/2020

Event Type  malfunction  

Manufacturer Narrative

The removed cannulae have been sent to syncardia for evaluation.The results will be provided in a follow-up mdr.(b)(4) initial.

Event Description

The customer, a syncardia certified hospital, reported that the patient presented in the emergency department with a leak in the right ventricular cannula approximately 7 cm from the cpc disconnect fitting (mfr report 3003761017-2020-00245).This cannula appeared to have gotten darker in color.The cannula appeared to have several spots where appearances of stresses have occurred.The cannula had a harder texture and did not feel to be as pliable since the last time mcs specialist saw him.It appears that the right ventricular cannula may have expanded or maybe delaminated on the inside.There was no reported adverse patient impact.The customer also reported that cannula was cleaned, a clear self-sealing silicon tape was applied to the leak site extending 2.5 cm to the sides of the hole.Three nylon cable ties were placed on the site to keep pressure on the self-sealing silicon tape to ensure a tight seal.Clear silicon tape was then placed over the nylon cable ties to protect the patient's skin.Both the right and the left cannulae were taped together to better support each other.The customer also reported that 5 days later, both the left and right damaged cannula were cut and spliced with new cannulae.

Manufacturer Narrative

The customer-reported issue of a cannula tear was captured in ce-5420 and closed on 23mar2021.Ce-5419 (b)(4) was opened for the issue of brittleness and discoloration.Visual inspection revealed both cannulae to be slightly darker in color and stiffer and brittle to the touch.The syncardia temporary total artificial heart (tah t) with the freedom driver system operator manual (f -900013 en) and the syncardia temporary total artificial heart (tah t) with the freedom driver system guidebook for patients and caregivers (f-900014 en) instruct patients to examine their cannulae regularly and to not use cleaners on the drivelines, cannulae, drivers, or driver accessories.Users are to use extreme care when cleaning the freedom driver and drivelines and to wipe the drivelines gently with a soft, clean cloth lightly dampened only with water.The root cause of the cannulae discoloration and stiffness was likely from exposure to a product in the patient's environment or a product that was applied topically to the cannulae and drivelines.This issue will be tracked and trended as part of the customer complaint process.Syncardia has completed its investigation and is closing this file.Ce 5419 (b)(4) follow-up report 1.

• Brand Name: SYNCARDIA 70CC TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T)
• Type of Device: BIVENTRICULAR REPLACEMENT DEVICE
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• Manufacturer (Section G): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• Manufacturer Contact: sagar pimpalwar ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 10945248
• MDR Text Key: 219523872
• Report Number: 3003761017-2020-00244
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 00858000003008
• UDI-Public: (01)00858000003008
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: 500101-001
• Device Catalogue Number: 500101
• Device Lot Number: 119223
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/13/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Sex: Male