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

Model Number 397002-001

Device Problems Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Loss of consciousness (2418)

Event Date 12/03/2018

Event Type  Injury  

Manufacturer Narrative

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) initial.

Event Description

The customer, a syncardia authorized distributor, reported that on (b)(6) 2018 the medical staff at the hospital responded to companion 2 driver alarms and found the patient unconscious on the floor.The customer also reported that the patient's fall from the bed provoked a disconnection of the patient from the driveline of the companion 2 driver.The patient was reconnected to the driveline properly and was intubated.The medical staff confirmed the hose tie which secures the driveline to the patient was missing because it was not found.The medical staff subsequently switched the patient to the backup driver.The customer also reported that on (b)(6) 2018 the medical staff decided to stop the medical care for the patient.The patient had not been well prior to the fall from his hospital bed.The cause of death was listed as multi-organ system failure and that the syncardia device did not cause or contribute to the patient's death.The tah-t was not explanted and no autopsy was performed.

Manufacturer Narrative

The cpc connector, driveline tubing and wire tie were not returned to syncardia, as they were not retained by the hospital.The patient data file was reviewed and revealed cardiac output alarms.The patient parameters during the time of the alarms indicated a drop in the cardiac output and fill volumes thus supporting the customer-reported experience of the driveline disconnection.The driver was functionally tested and met all acceptance criteria requirements.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).

• 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: 8239777
• MDR Text Key: 132795947
• Report Number: 3003761017-2019-00001
• 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: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 04/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 12/18/2018
• Initial Date Manufacturer Received: 12/12/2018
• Initial Date FDA Received: 01/11/2019
• Supplement Dates Manufacturer Received: 12/12/2018
• Supplement Dates FDA Received: 04/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 58 YR