MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA COMPANION DRIVELINES

Catalog Number 193002-001

Device Problems Air Leak (1008); Physical Property Issue (3008)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 02/05/2017

Event Type  malfunction  

Manufacturer Narrative

This alleged failure mode poses a low risk to a patient because the driveline issue did not prohibit the companion 2 driver from performing its life-sustaining functions.The companion drivelines will be returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.(b)(4).

Event Description

The customer, a syncardia certified hospital, reported that the companion drivelines had an air leak while supporting a patient.The customer also reported that backup drivelines were installed on the companion 2 driver.There was no reported adverse patient impact.

Manufacturer Narrative

The companion drivelines were returned to syncardia; however, syncardia procedure mfg-239, driver receiving and sanitation procedure, states that companion drivelines are to be disposed in the biohazardous waste container upon receipt.Therefore, no evaluation could be performed to confirm the customer-reported issue and determine a root cause.This issue will continue to be monitored and trended as part of the customer experience process.Syncardia has completed its evaluation of this complaint and is closing this file.Ce 4170 follow-up report 1.

• Brand Name: SYNCARDIA COMPANION DRIVELINES
• Type of Device: COMPANION DRIVELINES
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• MDR Report Key: 7286118
• MDR Text Key: 100779815
• Report Number: 3003761017-2018-00063
• Device Sequence Number: 1
• Product Code: LOZ
• Combination Product (y/n): N
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 06/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 193002-001
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 25 YR