MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, INC. SYNCARDIA COMPANION DRIVELINE

Catalog Number C-400008-001

Device Problems Filling Problem (1233); Fracture (1260); Device Stops Intermittently (1599)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/20/2014

Event Type  malfunction  

Event Description

The pt was implanted with a syncardia temporary total artificial heart (tah-t) on (b)(6) 2013 and was supported by a syncardia companion 2 driver.The customer reported that on (b)(6) 2014, she observed that one of the driver's drivelines had a fracture near the gray connector that connects the drivelines to the tah-t cannulae.The customer also reported that there was a brief and intermittent drop in filling when the driveline was moved.The pt's drivelines were replaced.The customer reported that neither the fracture nor the replacement of the drivelines had an adverse impact on the pt.This alleged failure mode poses a low risk to the pt because id did not prevent the companion 2 driver from performing its life-sustaining functions.An investigation will be conducted by syncardia, and the results will be provided in a supplemental mdr.

Manufacturer Narrative

The drivelines were returned to syncardia for evaluation.Visual inspection of the driveline tubing revealed no defects or damage.The investigation confirmed the customer experience of an air leak in the driveline assembly.The root cause of the air leak was a defect in the joint of the female cpc connector (inside the gray connector) between the hose barb and the housing.Without pressure forcing the two parts of the defective female cpc connector separated and allowed air to escape.The likely cause result of a manufacturing defect.Losing compressed air to the ventricle may pose a significant risk to the patient if not corrected.To mitigate the risk, the companion 2 driver system was designed to detect low driveline pressure, low flow events and imbalance between the performance of the right and left ventricles.Hospital staff are trained to be aware of the companion 2 driver pressure and system information and to notice and respond to extraordinary situations similar to what happened in this situation.Backup drivelines are provided as redundant parts to be readily available as additional mitigation.The drivelines were taken out of service.This is the only customer experience reporting a leak in the companion driveline.Customer experiences will continue to be monitored via syncardia's quality management system.Syncardia has completed its evaluation of this complaint and is closing this file.

• Brand Name: SYNCARDIA COMPANION DRIVELINE
• Type of Device: DRIVELINE
• Manufacturer (Section D): SYNCARDIA SYSTEMS, INC.; tucson AZ
• Manufacturer Contact: carole marcot, esq vp ; 1992 e. silverlake rd.; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 3907020
• MDR Text Key: 17383648
• Report Number: 3003761017-2014-00038
• Device Sequence Number: 1
• Product Code: LOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,health professional,use
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 03/06/2014

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 Catalogue Number: C-400008-001
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/25/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/20/2014
• Initial Date FDA Received: 03/06/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/11/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 19 YR