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

Catalog Number 397002-001

Device Problem Failure to Charge (1085)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 12/23/2016

Event Type  malfunction  

Manufacturer Narrative

This alleged failure mode poses a low risk to a patient because the issue was observed when the companion 2 driver was not supporting a patient.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 companion 2 driver was not supporting a patient.The customer, a syncardia certified hospital, reported that the companion 2 driver had an uncharged emergency battery after being plugged in to wall power overnight.

Manufacturer Narrative

Additional information from the customer was included.The companion 2 driver was returned to syncardia for evaluation.The customer-reported issue was confirmed during investigation testing.The emergency battery was found to be severely depleted and unable to recharge.The root cause of the inoperable emergency battery could not be conclusively determined based upon the information provided in the customer experience.However, storing the driver without external (wall) power can cause the emergency battery to deplete.The driver was not supporting a patient at the time of the event and the customer reported that the issue occurred during the driver system check therefore it is possible that the driver was in storage and was not plugged into wall power resulting in the deeply depleted state of the emergency battery.The companion 2 driver system operator manual provides guidance on driver storage requirements in section 12.10, which states, "always store companion 2 drivers in a hospital cart or caddy that is connected to external (wall) power." 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.(b)(4).

Event Description

The companion 2 driver was not supporting a patient.The customer, a syncardia certified hospital, reported that the companion 2 driver had an uncharged emergency battery after being plugged in to wall power overnight.

• 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
• Manufacturer Contact: michael garippa ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 6247903
• MDR Text Key: 65103830
• Report Number: 3003761017-2017-00006
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 00858000003107
• UDI-Public: (01)00858000003107
• 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 faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2017
• 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: 12/27/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/09/2015
• 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