MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, INC. SYNCARDIA COMPANION DRIVER; CIRCULATORY ASSIST DEVICE

Catalog Number 397002-001

Device Problem Device Displays Incorrect Message (2591)

Patient Problems Dyspnea (1816); Urinary Frequency (2275); No Code Available (3191)

Event Date 06/03/2015

Event Type  malfunction  

Event Description

The customer reported the companion 2 driver displayed a discrepancy between right and left fill volumes while supporting a patient.Right fill volume was reported as 45-50 and left fill volume was reported as 60-65.The left fill volume caused repeated fill volume high alarms.The customer also reported that the patient historically has been volume overloaded, and they were actively diuresing him.The customer also reported that the patient started feeling shortness of breath, but they did not attribute the symptoms to the companion 2 driver.The customer also reported that the patient was switched to the backup companion 2 driver without any adverse patient impact and is stable.This alleged failure mode poses a low risk to the patient because it did not prevent the driver from performing its life-sustaining functions.

Manufacturer Narrative

The companion 2 driver will be returned to syncardia for evaluation.The results of the investigation will be provided in a supplemental mdr.

Manufacturer Narrative

A review of the dhr confirmed that the driver was assembled according to procedure.The driver met all performance test acceptance criteria before its release to finished goods.The pt file was copied and reviewed, which revealed a "left fill volume high" alarm and a difference between the left and right fill volumes while the driver was connected to an external air source.This confirmed the customer-reported issue.Efforts to reproduce the "left fill volume high" alarm under the same conditions as recorded in the pt file were successful during failure investigation testing.However, this testing also proved that the pt condition of fluid volume overload resulted in the "left fill volume high" alarm.Component diagnostic testing with a replacement flow sensor and a replacement pressure sensor printed circuit assembly (pca) resulted in no alarms or anomalies.The difference between the left and right fill volumes were observed in both scenarios.The driver was supporting a pt at the time of the customer-reported issue of a "left fill volume high" alarm.Failure investigation testing demonstrated that the pt condition of fluid volume overload resulted in the alarm showing this alarm was operating as intended.Efforts to reproduce the discrepancy between the left and right fill volumes were successful during failure investigation testing.The root cause of the discrepancy is unknown.The fill volumes displayed on the driver are for reference only.The driver was serviced and passed all final performance testing.Risk to the pt was low because the driver operated as intended and continued to perform its life-sustaining functions.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.

• Brand Name: SYNCARDIA COMPANION DRIVER
• Type of Device: CIRCULATORY ASSIST DEVICE
• Manufacturer (Section D): SYNCARDIA SYSTEMS, INC.; tucson AZ
• Manufacturer Contact: carole marcot, esq, vp ; 1992 e. silverlake rd.; ce 2834; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 4892620
• MDR Text Key: 17632972
• Report Number: 3003761017-2015-00204
• 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: 06/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 397002-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 29 YR