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

Model Number 500101-001

Device Problems Connection Problem (2900); Positioning Problem (3009)

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

Event Date 04/11/2018

Event Type  malfunction  

Manufacturer Narrative

The 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 cpc (colder products company) connector is a component that provides the interface between the driver drivelines and the tah-t cannula.The customer, a syncardia certified hospital, reported that the left cpc connector on the tah-t had a displaced spring.The customer also reported that the cpc connector was replaced.There was no reported adverse patient impact.

Manufacturer Narrative

The cpc (colder products company) connector was returned to syncardia for evaluation.Visual inspection confirmed the customer-reported dislodged spring, as the spring inside the female cpc connector was displaced inside the housing.Although a definitive root cause for the spring displacement 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.Syncardia has a corrective and preventive action (capa) to address this issue.Syncardia has completed its evaluation of this complaint and is closing this file.(b)(4) follow-up report 1.

Event Description

The cpc (colder products company) connector is a component that provides the interface between the driver drivelines and the tah-t cannula.The customer, a syncardia certified hospital, reported that the left cpc connector on the tah-t had a displaced spring.The customer also reported that the cpc connector was replaced.There was no reported adverse patient impact.

• 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: 7454253
• MDR Text Key: 107083147
• Report Number: 3003761017-2018-00139
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 00858000003008
• UDI-Public: (01)00858000003008
• 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
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 04/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Model Number: 500101-001
• Device Catalogue Number: 500101
• Device Lot Number: 102641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 60 YR