MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, INC. SYNCARDIA COMPANION DRIVER CADDY

Catalog Number 397001-001

Device Problem Failure to Charge (1085)

Patient Problem No Patient Involvement (2645)

Event Date 07/27/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The companion driver caddy was not in use by a pt.The companion driver caddy is a small cart with wheels into which the companion 2 driver docks.It is designed to facilitate mobility of stable pts while in the hospital.The caddy can be plugged into external wall power to provide a redundant power source to the docked companion 2 driver.The customer reported that the companion driver caddy could not charge the batteries on the companion 2 driver.This alleged failure mode poses a low risk to a pt because the issue was observed when the companion driver caddy was not in use by a pt.In additional, it would not prevent the companion 2 driver from performing its life-sustaining functions.The companion 2 driver also has redundant, alternate power sources of external batteries and an internal, emergency battery.

Manufacturer Narrative

(b)(4).

Event Description

The companion driver caddy was not in use by a patient.The companion driver caddy is a small cart with wheels into which the companion 2 driver docks.It is designed to facilitate mobility of stable patients while in the hospital.The caddy can be plugged into external wall power to provide a redundant power source to the docked companion 2 driver.The customer reported that the companion driver caddy could not charge the batteries on the companion 2 driver.Visual inspection of the exterior of the caddy revealed no damage or anomalies.A visual inspection of the interior of the caddy components and workmanship revealed no damage or anomalies.The caddy passed all performance testing, and the customer-reported issue could not be duplicated.The investigation determined that the caddy performed as intended and there was no evidence of a device malfunction.The companion caddy was not in patient use at the time of the reported issue; therefore, there was no patient impact.In addition, this issue would not prevent a companion 2 driver from performing its life-sustaining functions.The companion caddy provides a redundant power source of external wall power to the companion 2 driver.The companion 2 driver could also be switched to another caddy or a hospital cart.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 CADDY
• Type of Device: CADDY
• 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: 4987728
• MDR Text Key: 23397834
• Report Number: 3003761017-2015-00246
• Device Sequence Number: 1
• Product Code: LOZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Report Date: 07/27/2015

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: Other Health Care Professional
• Device Catalogue Number: 397001-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2011
• 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