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

Model Number 595000-001

Device Problems Charging Problem (2892); Audible Prompt/Feedback Problem (4020)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/22/2019

Event Type  malfunction  

Manufacturer Narrative

This alleged failure mode poses a low risk to the patient because the reported issue did not prevent the freedom driver from performing its life-sustaining functions.The freedom driver has been 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 a patient's freedom driver did not charge the freedom onboard batteries and the led on the power adaptor was not illuminated.The customer also reported that the leds on the patient's freedom onboard batteries did not blink when the test button was pressed and that the patient changed the freedom onboard batteries several times and subsequently the freedom driver exhibited a red alarm while supporting the patient.The customer also reported that the patient was switched to the backup freedom driver.There was no reported adverse patient impact.

Manufacturer Narrative

The customer-reported issue was confirmed during the internal visual inspection, prior to functional testing, where it was observed that the pins in the p2 connector of the connection 1 receptacle cable were not making any contact with the connector on the main printed circuit board which would result in the onboard batteries not charging.After the wire pins were fully inserted into the connector, the driver passed functional testing.Additionally, an onboard battery discharge/recharge test was performed and the driver functioned as intended.The root cause of the batteries not charging while inserted in the driver was determined to be the loose wire pins in p2 connector of connection 1 receptacle cable.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.

Manufacturer Narrative

Corrected data section h6.(b)(4) follow-up report 2.

• 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: 8610258
• MDR Text Key: 145138802
• Report Number: 3003761017-2019-00101
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 09/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2019
• 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: 04/26/2019
• Date Manufacturer Received: 04/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 47 YR