MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA 70CC TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T); BIVENTRICULAR REPLACEMENT DEVICE

Model Number 595000-001

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/13/2019

Event Type  malfunction  

Manufacturer Narrative

This alleged failure mode poses low risk to the patient because the reported issue did not prevent the 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 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 spring in the freedom drivers' cpc connector was broken.There was no reported adverse patient impact.The customer also reported that the patient was subsequently switched to a backup freedom driver.

Manufacturer Narrative

During the course of the investigation, it was discovered that the tah-t cpc connector was attached to the freedom driver driveline and that was the cpc connector with the issue.Therefore, the appropriate fields in sections b and d have been corrected to reflect the change in product from freedom driver to tah-t.Visual inspection could not confirm the customer-reported issue of a broken spring, as the spring was missing from within the housing, beneath the metal thumb release tab.It is likely that a broken or displaced spring could result in the spring becoming completely dislodged and missing from beneath the metal thumb release tab.Clinicians and patients are trained to thread a wire tie beneath the thumb release tab of the cpc connectors to prevent accidental disconnection of the cannulae from the drivelines.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 and is closing this file.(b)(4) follow-up report 1.

Event Description

The customer, a syncardia certified hospital, reported that the spring in the tah-t cannula's cpc connector was broken.

• Brand Name: SYNCARDIA 70CC TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T)
• Type of Device: BIVENTRICULAR REPLACEMENT DEVICE
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• MDR Report Key: 9141513
• MDR Text Key: 161040512
• Report Number: 3003761017-2019-00285
• 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: 11/04/2019

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: Health Professional
• Device Model Number: 595000-001
• Device Catalogue Number: 500101
• Device Lot Number: 106901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2019
• Initial Date Manufacturer Received: 09/13/2019
• Initial Date FDA Received: 10/01/2019
• Supplement Dates Manufacturer Received: 09/13/2019
• Supplement Dates FDA Received: 11/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 45 YR