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

Catalog Number 397002-001

Device Problems Failure to Charge (1085); Device Displays Incorrect Message (2591); Battery Problem (2885)

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

Event Date 04/25/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

This companion 2 driver was not supporting a patient.The customer reported that the internal, emergency battery of the companion 2 driver could not be charged, even though the driver was connected to wall power for more than 24 hours.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.In addition, it would not prevent the companion 2 driver from performing its life-sustaining functions.The companion 2 driver has redundant power sources of external batteries and external wall power.The companion 2 driver will be returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.

Manufacturer Narrative

(b)(4).

Event Description

This companion 2 driver was not supporting a patient.The customer reported that the internal, emergency battery of the companion 2 driver could not be charged, even though the driver was connected to wall power for more than 24 hours.The companion 2 driver was returned to syncardia for evaluation.Visual inspection of the driver's external components revealed no anomalies.The electronic patient data file was reviewed, revealing two "emergency battery error" alarms.During investigation testing, the "emergency battery error" alarm was not reproduced.However, further testing revealed that the emergency battery could not maintain operation of the driver for ten minutes, indicating that the emergency battery had reduced capacity.It is likely that the reported issue and "emergency battery error" alarms recorded in the electronic patient data file were the result of the emergency battery not being able to be charged to full capacity.The emergency battery was replaced, and the companion 2 driver passed all final performance testing.This failure mode poses a low risk to a patient because the issue was observed when the companion 2 driver was not supporting a patient.In addition, it would not prevent the companion 2 driver from performing its life-sustaining functions.The companion 2 driver has redundant power sources of external batteries and 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.

• 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: 5626188
• MDR Text Key: 44780834
• Report Number: 3003761017-2016-00185
• 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: Biomedical Engineer
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 04/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2016
• 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: 05/03/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/22/2011
• 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