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

Model Number 397002-001

Device Problems Device Emits Odor (1425); Device Displays Incorrect Message (2591); Computer Operating System Problem (2898)

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

Event Date 03/05/2018

Event Type  malfunction  

Manufacturer Narrative

This alleged failure mode poses a low risk to the 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 reported issues involve the following syncardia temporary total artificial heart (tah-t) system components and are reported under two separate medical device reports: companion 2 driver s/n (b)(4) (mfr report # 3003761017-2018-00088) and companion hospital cart s/n (b)(4) (mfr report # 3003761017-2018-0114).The companion 2 driver was not supporting a patient.The customer, a syncardia certified hospital, reported that the companion 2 driver was docked in the companion hospital cart and passed the system check out procedure.After the system check, the driver gave an audible alarm without an alarm message and a burning electrical smell was noted.The driver was powered off and removed from the hospital cart.The customer also reported that a few days later the driver was docked into a different companion hospital cart and again checked, this time the driver gave a computer malfunction alarm.

Manufacturer Narrative

The driver in "as received" condition passed all test sections with no alarms or odor.During investigation testing, the driver performed as intended with no evidence of a device malfunction as is reported under mfr.3003761017-23018-00088 (companion 2 driver s/n (b)(4)).The customer-reported computer malfunction alarm was confirmed during patient data file review.This computer malfunction alarm is indicative of a sudden loss of power to the driver, which will appear upon the next driver startup.It was determined that power supply of the hospital cart in which the companion 2 driver was docked was malfunctioning and therefore unable to adequately power the companion 2 driver.The companion hospital cart s/n (b)(4) is reported under mfr.3003761017-23018-00114.This issue will continue to be monitored and trended as part of the customer experience process.Syncardia has completed its evaluation and is closing this file.(b)(4) 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: 7390833
• MDR Text Key: 104271672
• Report Number: 3003761017-2018-00088
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 00858000003107
• UDI-Public: (01)00858000003107
• Combination Product (y/n): N
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 08/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 397002-001
• Device Catalogue Number: 397002-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1