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

Model Number 500101-001

Device Problems Disconnection (1171); Mechanical Problem (1384)

Patient Problem Loss of consciousness (2418)

Event Date 06/05/2019

Event Type  Injury  

Manufacturer Narrative

The 70cc tah-t remains implanted and the freedom driver continues to support the patient.The results of the investigation will be provided in a followup 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 patient got the drivelines trapped in a recliner and when he stood up the cannulae disconnected at the cpc connector and the freedom driver alarmed.The customer also reported that the patient had the zip ties covered in tape which delayed reconnection and the patient lost consciousness for 3-4 minutes.The customer also reported that the patient regained consciousness after the cannulae were reconnected to the drivelines.The patient remains supported by the freedom driver.

Manufacturer Narrative

Per (b)(4), freedom driver system operator manual - us, clinicians and patients are trained to secure the cpc connector in the cannula and driveline tubing using at least two wire ties to prevent accidental disconnection of the drivelines from the cannulae.(b)(4) also instructs the user to avoid kinking and tugging of drivelines.The site reported that zip ties were in place but that the drivelines were tugged, as they were caught in a recliner as the patient stood up and were disconnected from the cannula, at the time of the reported issue.Detachment or disconnection of drivelines from tah-t cannulae is addressed in (b)(4), tah-t design failure modes and effects analysis (dfmea) and (b)(4), freedom® driver system applications failure modes and effects analysis (afmea).Mitigating action for this issue includes wire ties applied around the barbed portion of the cpc connectors.As noted in the reported issue, the wire ties used to prevent accidental disconnection were in place but were covered in tape at the time of the reported issue, which may be a contributing factor in the delay in freedom driver reconnection which resulted in the patient losing consciousness.Freedom driver and tah-t labeling does not instruct clinicians or patients to cover the wire ties to prevent patient discomfort.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.

• 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: 8719774
• MDR Text Key: 148760469
• Report Number: 3003761017-2019-00196
• 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: Repair
• Type of Report: Initial,Followup
• Report Date: 07/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: 500101-001
• Device Catalogue Number: 500101
• Device Lot Number: 116749
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR