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

Catalog Number 397002-001

Device Problems Filling Problem (1233); Device Displays Incorrect Message (2591)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 11/16/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reported that the companion 2 driver exhibited sudden drops in fill volumes while supporting a patient at (b)(6).The customer also reported that the patient was subsequently switched to the backup companion 2 driver.There was no reported adverse patient impact.This alleged failure mode poses a low risk to the patient because although the companion 2 driver exhibited sudden drops in fill volumes, it did not prevent the driver from performing its life-sustaining functions.The companion 2 driver will be returned to syncardia for evaluation.The results of the evaluation will be provided in a follow-up mdr.

Manufacturer Narrative

(b)(4).

Event Description

The customer reported that the companion 2 driver exhibited sudden drops in fill volumes while supporting a patient at the (b)(6).The customer also reported that the patient was subsequently switched to the backup companion 2 driver.There was no reported adverse patient impact.The companion 2 driver was returned to syncardia for evaluation.Visual inspection of the driver's internal components revealed no anomalies.The patient file was copied and reviewed, revealing no anomalies that would indicate a malfunction of the driver.During investigation testing, the left and right fill volumes were shown to be stable with no sudden fluctuations observed.Therefore, the root cause of the customer-reported issue could not be determined.It is possible that the reported fill volume changes were related to the patient's condition.The driver performed as intended, and there was no evidence of a device malfunction.Despite the customer-reported drop in fill volumes, risk to the patient was low because the driver continued to perform its life-sustaining functions, and the customer reported that there was no adverse impact to the patient.The companion 2 driver was serviced and passed all functional and performance testing before being placed into finished goods.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 2 DRIVER
• Type of Device: EXTERNAL PNEUMATIC DRIVER
• Manufacturer (Section D): SYNCARDIA SYSTEMS, INC.; 1992 e. silverlake road; tucson AZ 85713
• Manufacturer Contact: carole marcot ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 5243129
• MDR Text Key: 32121234
• Report Number: 3003761017-2015-00398
• 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: distributor,foreign,health pr
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 11/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2015
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/29/2014
• 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: 57 YR