MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA COMPANION 2 DRIVER; EXTERNAL PNEUMATIC DRIVER

Catalog Number 397002-001

Device Problems Filling Problem (1233); Low Readings (2460)

Patient Problems No Consequences Or Impact To Patient (2199); Complaint, Ill-Defined (2331)

Event Date 06/21/2017

Event Type  malfunction  

Manufacturer Narrative

The companion 2 driver has been returned to syncardia for evaluation.The results of the evaluation will be provided in a follow-up mdr.(b)(4).

Event Description

The customer, a syncardia authorized distributor, reported that the patient stated he didn't feel well and then the companion 2 driver experienced a fill volume drop to zero.The customer also reported that there was no clinical impact on the patient and the patient was subsequently switched to a backup driver without any reported adverse patient impact.

Manufacturer Narrative

Corrected data: describe event or problem: additional information from customer added.The companion 2 driver was returned to syncardia for evaluation.The customer-reported right overpressure alarms and drop in left fill volume were confirmed via review of the patient data file and driver alarm history and reproduced during investigation testing.The root cause of the right overpressure alarm was determined to be a malfunction of the right electronic pressure regulator.The root cause of the drop in left fill volume was determined to be a malfunction of the left pilot valve.Syncardia has a corrective and preventive action (capa) to address the pilot valve issue.Syncardia has completed its evaluation of this complaint and is closing this file.(b)(4) follow-up report 1.

Event Description

The customer, a syncardia authorized distributor, reported that the companion 2 driver exhibited right overpressure alarms while supporting the patient.The customer also reported that the patient stated he didn't feel well and then the companion 2 driver experienced a fill volume drop to zero.The customer also reported that there was no clinical impact on the patient and the patient was subsequently switched to a backup driver without any reported adverse patient impact.

• Brand Name: SYNCARDIA COMPANION 2 DRIVER
• Type of Device: EXTERNAL PNEUMATIC DRIVER
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• MDR Report Key: 6680534
• MDR Text Key: 79037461
• Report Number: 3003761017-2017-00119
• Device Sequence Number: 1
• Product Code: LOZ
• Combination Product (y/n): N
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 06/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2017
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2017
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 54 YR