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

Model Number 500101-001

Device Problem Material Integrity Problem (2978)

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

Event Date 10/08/2020

Event Type  malfunction  

Manufacturer Narrative

The cpc connector with attached cannula will be 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 indicated that the patient side cpc connector had fallen out of the cannula.Patient has known crack/leak at this side that has been repaired before and has essentially been bandaged for months with rescue tape and new zip ties.Upon assessment in clinic there was a palpable leak of air between the connector and the cpc.There was question of a crack.The hospital also reported that they cut the cannula just above the cpc connector and attached a new connector.Patient tolerated without adverse effect.Upon investigating the removed portion, the hospital reported that it appeared that one of the wires, from the cannula, was interfering on the side.

Manufacturer Narrative

Visual inspection revealed that a piece of the cannula reinforced wire had protruded the cannula wall and had accumulated in the space between the inner diameter and cpc connector barb.This created a visible gap and was most likely the root cause for the reported air leak and issue of easy disconnection of the cpc connector.There was no evidence of a tear or crack in the cannula.This issue will be monitored and trended as part of the customer complaint process.Syncardia has completed its investigation and is closing this file.(b)(4) follow-up report 1 (1 of 2).

• Brand Name: SYNCARDIA 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: 10705488
• MDR Text Key: 214799666
• Report Number: 3003761017-2020-00216
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Model Number: 500101-001
• Device Catalogue Number: 500101
• Device Lot Number: 106901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/08/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2016
• 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: 46 YR
• Patient Sex: Male