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

Model Number 595000-001

Device Problems Component Missing (2306); Connection Problem (2900)

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 spring on the right cpc connector was missing, the freedom driver continued to perform 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 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 was missing the spring.The customer also reported that the patient was subsequently switched to a backup freedom driver.There was no reported adverse patient impact.

Manufacturer Narrative

The customer-reported issue of a missing spring was confirmed during the visual inspection of the driver's external components, where there was no spring in the female cpc connector.Despite the spring missing from the cpc connector housing, the drivelines were able to be connected to a tah-t during investigation testing, and the driver passed all test sections.Although a definitive root cause for the spring coming out of the cpc connector housing could not be determined, it is possible that a cpc connector spring can be displaced during the insertion of a wire tie, or pulled out of the connector housing when the wire tie is removed from the connector during or after a driver switch.As reported by the customer, the missing spring could have been caused by the way the zip (wire) ties were being placed, which would align with the determined failure mode.Syncardia has an open corrective and preventive action (capa) to address this issue with cpc connectors.Syncardia has completed its evaluation and is closing this file.Ce 4218 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: 7377396
• MDR Text Key: 103951176
• Report Number: 3003761017-2018-00095
• 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
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 11/26/2018

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: 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: 03/16/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 43 YR