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

Model Number 595000-001

Device Problems Break (1069); Connection Problem (2900)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 03/15/2018

Event Type  malfunction  

Manufacturer Narrative

This alleged failure mode poses a low risk to a patient because the issue was observed when the freedom driver was not supporting a patient.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 freedom driver was not supporting the patient at the time of the event.The cpc (colder products company) connector is a component that provides the interface between the drivelines and the tah-t cannula.The customer, a syncardia certified hospital, reported that the right cpc connector on the freedom driver had a broken spring.The customer also reported that the driver was being used for training when the issue was noticed.

Event Description

The freedom driver was not supporting the patient at the time of the event.The cpc (colder products company) connector is a component that provides the interface between the drivelines and the tah-t cannula.The customer, a syncardia certified hospital, reported that the right cpc connector on the freedom driver had a broken spring.The customer also reported that the driver was being used for training when the issue was noticed.

Manufacturer Narrative

The freedom driver was returned to syncardia for evaluation.The customer-reported issue of a displaced spring in the cpc connector was confirmed during the visual inspection of the driver's external components.Despite the displaced spring, the drivelines were able to be connected to a tah-t during investigation testing and the driver passed all test sections in freedom driver final test and acceptance procedure.Although a definitive root cause for the displaced spring could not be determined, it is possible that a cpc connector spring can be displaced when the wire tie is threaded through, or removed from, the connector during or after a driver switch or during driver training.Syncardia has an open corrective and preventive action (capa) to address this issue with cpc connectors.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: 7377401
• MDR Text Key: 103944764
• Report Number: 3003761017-2018-00099
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 03/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 595000-001
• Device Catalogue Number: 595000-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 66 YR