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

Catalog Number 397002-001

Device Problem Audible Prompt/Feedback Problem (4020)

Patient Problem No Patient Involvement (2645)

Event Date 10/14/2019

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 is being evaluated by syncardia.The results of the investigation will be provided in a follow-up mdr.(b)(4).

Event Description

While performing a routine evaluation, a syncardia technician reported that the companion 2 driver did not pass the system check procedure.

Manufacturer Narrative

The reported issue of the driver not passing the system check was confirmed through the patient file review, which indicated an issue with the 9 volt battery.During investigation testing, the 9 volt battery voltage was found to be below the required range.Additional testing reproduced the results reported issue and the 9 volt battery was found to have been drained below acceptable limits.Previous investigations determined the root cause to be a malfunction of the 9 volt battery switch board assembly, causing a higher than normal current drain that results in premature 9 volt battery depletion.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.Ce 5005 follow-up report 1.

• 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: 9214146
• MDR Text Key: 163063998
• Report Number: 3003761017-2019-00310
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 000858000003107
• UDI-Public: (01)000858000003107
• Combination Product (y/n): N
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 11/19/2019

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
• Device Catalogue Number: 397002-001
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/14/2019
• Initial Date FDA Received: 10/21/2019
• Supplement Dates Manufacturer Received: 10/14/2019
• Supplement Dates FDA Received: 11/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1