MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, INC. SYNCARDIA COMPANION 2 DRIVER; CIRCULATORY ASSIST DEVICE

Catalog Number 397002-001

Device Problem Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138)

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

Event Date 04/10/2015

Event Type  malfunction  

Event Description

The customer reported that the screen display of the companion 2 driver "froze" while supporting a patient at (b)(6).The patient was subsequently switched to the backup companion 2 driver.There was no reported adverse patient impact.The customer sent the electronic patient data file to syncardia and requested that the data be reviewed to determine if the companion 2 driver was performing as intended or whether the driver should be returned to syncardia for evaluation.Review of the electronic patient data file determined that although there was very little fluctuation in values, which may have correlated to the activity of the patient, there was no evidence of any "freezing" of the information logged.

Manufacturer Narrative

Review of the electronic patient data file confirmed that the companion 2 driver performed as intended and was ready for clinical use.The customer acknowledged the results of the data file review and reported that the companion 2 driver would not be returned to syncardia.The reported issue posed a low risk to the patient because it did not prevent the driver from performing its life--sustaining functions.Syncardia has completed its evaluation of this complaint and is closing this file.

• Brand Name: SYNCARDIA COMPANION 2 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.; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 4756702
• MDR Text Key: 5887392
• Report Number: 3003761017-2015-00143
• Device Sequence Number: 1
• Product Code: LOZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 04/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 397002-001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/10/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/01/2014
• 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: 48 YR