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

Catalog Number 193002-001

Device Problems Material Integrity Problem (2978); Material Split, Cut or Torn (4008)

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

Event Date 10/03/2020

Event Type  malfunction  

Manufacturer Narrative

The companion drivelines will be returned to syncardia for evaluation.The results will be provided in a follow-up mdr.(b)(4).

Event Description

The customer, a syncardia authorized distributor, reported that the companion drivelines had a suspected 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

During evaluation, the companion drivelines were connected to companion 2 driver s/n (b)(6) and the post-burn-in sections of mfg 189, companion 2 driver final assembly functional test procedure were performed.The driver functioned as intended during testing with passing results.After functional testing with the companion 2 driver, the driver remained pumping with the drivelines attached and a leak test was performed.Snoop liquid leak detector (p/n 600129-001 l/n 033064) was applied to the full length of the drivelines and the drivelines were tested for any leaks.During this test no leaks were observed.Additionally, all zip ties and o-rings were found to be intact and the drivelines were free from any punctures or tears.The companion drivelines performed as intended with no evidence of a device malfunction.The root cause of the customer-reported issue could not be conclusively determined.This issue will be monitored and trended as part of the customer experience process.Syncardia has completed its investigation and is closing this file.Ce 5392 follow-up report 1.

• Brand Name: SYNCARDIA
• Type of Device: COMPANION DRIVELINES
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• MDR Report Key: 10820134
• MDR Text Key: 215913408
• Report Number: 3003761017-2020-00220
• 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: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 12/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2020
• 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: 118375
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2020
• Date Manufacturer Received: 10/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 66 YR