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

Model Number 500101-001

Device Problem Material Too Rigid or Stiff (1544)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/05/2018

Event Type  malfunction  

Manufacturer Narrative

This alleged failure mode poses a low risk to the patient because the stiffness of the cannulae did not prevent the tah-t system from performing its life-sustaining function.The stiff sections of the 70cc tah-t cannulae remain on the patient; therefore no cannulae will be returned to syncardia for evaluation.Syncardia will conduct a review of the tah-t device history record (dhr) and previous occurrences of stiff cannulae.The results will be provided in a follow-up mdr.(b)(4).

Event Description

The customer, a syncardia certified hospital, reported that both cannulae of the 70cc tah-t were very stiff.The customer also reported that the patient exposed the cannulae at one time to a lot of sun and extreme temperatures, and cleaned the cannulae with disinfectant and alcohol.

Manufacturer Narrative

Review of the device history record, both base/cannula shop orders, the incoming inspection logs, and the sterilization work order found no anomalies.All manufacturing was performed to specifications.The tah-t met all specified requirements prior to shipment.The hospital provided a picture of the left cannula to show the cannula tear (mfg 3003761017-2018-00530).The stiffness of the cannulae is unable to be confirmed from the picture.The patient reported that at one time the cannulae were exposed to a lot of sun and hot temperatures (40°c).The patient also mentioned that the cannulae were sometimes cleaned with a disinfectant including alcohol.The syncardia temporary total artificial heart (tah t) with the freedom driver system operator manual and the syncardia temporary total artificial heart (tah t) with the freedom driver system guidebook for patients and caregivers 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.Environmental exposure could have led to loss of plasticizers from the cannula material, and material stability and mechanical performance of pvc is negatively affected by aging.The root cause of the customer-reported stiffened cannulae cannot be conclusively determined but it is consistent with previously reported cannula stiffness.This issue will continue to be monitored and trended as part of the customer experience process.Syncardia has completed its evaluation and is closing this file.Ce 4553 follow-up report 1.

• Brand Name: SYNCARDIA 70CC TEMPORARY TOTAL ARIFICIAL HEART (TAH-T)
• Type of Device: BIVENTRICULAR REPLACEMENT DEVICE
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• MDR Report Key: 8113011
• MDR Text Key: 129340664
• Report Number: 3003761017-2018-00531
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 00858000003008
• UDI-Public: (01)00858000003008
• Combination Product (y/n): N
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 02/18/2019

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: Health Professional
• Device Expiration Date: 08/31/2017
• Device Model Number: 500101-001
• Device Catalogue Number: 500101
• Device Lot Number: 094327
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/05/2018
• Initial Date FDA Received: 11/28/2018
• Supplement Dates Manufacturer Received: 07/05/2018
• Supplement Dates FDA Received: 02/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 60 YR