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

Model Number 595000-001

Device Problems Electrical /Electronic Property Problem (1198); Device Displays Incorrect Message (2591)

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

Event Date 03/13/2018

Event Type  malfunction  

Manufacturer Narrative

This alleged failure mode poses a low risk to the patient because although the freedom driver exhibited a fault alarm, it continued to perform its life-sustaining functions.The freedom driver 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 authorized distributor, reported that the freedom driver exhibited a fault alarm while supporting the patient.The customer also reported that the patient switched to the backup freedom driver.There was no reported adverse patient impact.

Manufacturer Narrative

Visual inspection of the driver's internal components revealed a broken white wire and frayed insulation on the red wire of the flow sensor to the main printed circuit board assembly (pcba) cable.The alarm history was reviewed and revealed one recorded alarm - a 22 fault code, correlating with a sudden change in voltage detected (fluctuations detected in a time frame of less than or equal to 1 second) during operation of the driver.This alarm was produced by the malfunction of the airflow sensor cable, which was found to be severed, and was the cause of the customer-reported alarm.Syncardia has an open corrective and preventative action (capa) that determined the assembly routing was causing the air flow sensor cable wires to become pinched between two internal driver components during or following driver assembly.This pinching appears to precipitate a severing of the wire.Syncardia has completed its evaluation 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: 7358321
• MDR Text Key: 103292397
• Report Number: 3003761017-2018-00096
• 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: distributor,foreign,health pr
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 08/01/2018

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: 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: 04/03/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/13/2018
• Initial Date FDA Received: 03/21/2018
• Supplement Dates Manufacturer Received: 03/13/2018
• Supplement Dates FDA Received: 08/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 16 YR