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

Catalog Number 397002-001

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Loss of consciousness (2418)

Event Date 12/12/2016

Event Type  Injury  

Manufacturer Narrative

The companion 2 driver was returned to syncardia for evaluation.Review of the patient data file revealed no alarms, indicating that there was no device malfunction.The logger file stored in the patient file recorded a shutdown command corresponding to the customer-reported issue.This command is only logged when the key switch is turned to the "off" position, meaning that the driver was turned off due to the key being turned to the "off" position while the driver was in use.The root cause of the unexpected shutdown is the operation key was not removed from the driver while it was in use and subsequent contact with an unknown force most likely bent the key toward the "off" position and initiated a driver shutdown sequence.Companion 2 driver system operator manual english - us, contains multiple instructions to remove the key once the driver is powered on.Section 6.3, paragraph 5 states, "when the driver is on, the key must be removed from the driver to prevent unintended interruptions to driver operation.Once removed, the key may be stored in a location determined by the clinical staff." sections 8.1.5 and 8.1.6 respectively state, "turn the driver on by rotating the key clock-wise," and "remove the key from the driver and store in a location determined by the clinical staff." section 12.9 states, "remove the key from the key switch when the driver is in operation.The key cannot be removed when the driver is switched off." staff at the hospital where this event occurred are being retrained to remove the key after it is moved to the on position on the driver.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) initial.

Event Description

The customer, a syncardia certified hospital, reported that the key to the companion 2 driver in use on the patient was in the driver when the driver stopped pumping, at which point the patient was pumped with a hand pump while a backup driver was turned on and placed on the patient.The customer also reported that there was no permanent adverse patient impact.

• 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: carole marcot ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 6245448
• MDR Text Key: 64616291
• Report Number: 3003761017-2017-00012
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 000858000003107
• UDI-Public: (01)000858000003107
• 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
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 12/12/2016

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?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 397002-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/27/2012
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 27 YR