MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA FREEDOM DRIVER; EXTERNAL PNEUMATIC DRIVER

Model Number 595000-001

Device Problems Air Leak (1008); Split (2537); Connection Problem (2900)

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

Event Date 02/06/2018

Event Type  malfunction  

Manufacturer Narrative

This alleged failure mode poses a low risk to the patient because the freedom driver continued to perform its life-sustaining functions.The o-ring of the freedom driver cpc connector 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 after the patient was switched onto freedom driver s/n (b)(4), the vad coordinator heard a small air leak at the left ventricle cpc connection.On examination, the vad coordinator found the freedom driver cpc connector o-ring split into 3 pieces lying on the patient's bed.The customer also reported that the vad coordinator then switched the patient to the hospital standby freedom driver and the leak ceased.The vad coordinator then took the o-ring from the cpc connector of a freedom driver returning to syncardia and put it on the cpc connector of freedom driver s/n (b)(4).The customer also reported that the patient is using freedom driver s/n (b)(4) as his backup freedom driver and only the pieces of the o-ring will be returned to syncardia.

Event Description

The customer, a syncardia certified hospital, reported that after the patient was switched onto freedom driver s/n (b)(4), the vad coordinator heard a small air leak at the left ventricle cpc (colder products company) connection.On examination, the vad coordinator found the freedom driver cpc connector o-ring split into 3 pieces lying on the patient's bed.The customer also reported that the vad coordinator then switched the patient to the hospital standby freedom driver and the leak ceased.The vad coordinator then took the o-ring from the cpc connector of a freedom driver returning to syncardia and put it on the cpc connector of freedom driver s/n (b)(4).The customer also reported that the patient is using freedom driver s/n (b)(4) as his backup freedom driver and only the pieces of the o-ring will be returned to syncardia.

Manufacturer Narrative

The o-ring of the freedom driver cpc (colder products company) connector was returned to syncardia for evaluation.Visual inspection confirmed the customer-reported issue, as the o-ring from the freedom driveline female cpc connector was broken into three pieces.During physical examination of the o-ring pieces, the pieces were qualitatively compared to a new, intact cpc connector o-ring for stiffness.When force was applied to the returned cpc connector o-ring pieces and a new o-ring (pressed between thumb and index finger), the material of the returned o-ring pieces rebounded about the same as the new o-ring.The returned o-ring pieces were not notably more rigid or dried out during this physical examination.Because of the broken o-ring, it is possible that a sealed connection between the left driveline and the left side tah-t cannula could not be made, which could have resulted in the customer-reported air leak noise.A definitive root cause for the broken o-ring could not be determined.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.(b)(4) follow-up report 1.

• Brand Name: SYNCARDIA FREEDOM DRIVER
• Type of Device: EXTERNAL PNEUMATIC DRIVER
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• MDR Report Key: 7301106
• MDR Text Key: 101261261
• Report Number: 3003761017-2018-00070
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 00858000003121
• UDI-Public: (01)00858000003121
• 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
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 02/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 595000-001
• Device Catalogue Number: 595000-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 59 YR