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

Model Number 397002-001

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Loss of consciousness (2418)

Event Date 04/07/2017

Event Type  Injury  

Manufacturer Narrative

The companion 2 driver was returned to syncardia for evaluation.Review of the patient data file revealed a drop in left and right cardiac output (co), as well as left and right fill volumes (fv), which confirmed the conditions resulting in the customer-reported issue of a low cardiac output alarm.The low co reported by the customer was reproduced during investigation testing.The root cause of this issue was identified as malfunction of the pilot valves.The pilot valves have been sent to a contract laboratory for further evaluation.The results of this evaluation will be provided in a follow-up mdr.(b)(4).

Event Description

The customer, a syncardia certified hospital, reported that the companion 2 driver exhibited a low cardiac output alarm while supporting a patient.The customer also reported that the patient began to lose consciousness, then became unresponsive and exhibited "seizure like" behavior.The customer also reported that the patient was switched to a back-up companion 2 driver and very quickly started responding and moving and is now back to normal.

Manufacturer Narrative

The pilot valves, along with associated components, were sent to a contract laboratory for further evaluation.The contract laboratory investigation uncovered and chemically identified various contaminants throughout the submitted components that may have impacted the function of the suspect pilot valves.Based on the information and material provided, specific origin of the various contaminants analyzed cannot be determined with certainty, however, similar compositions of residue/debris located in the pilot valves and the air line that goes from the external air connector to the manual pressure regulator (located prior to the pilot valves), suggest that some level of contamination may be coming from external air.Syncardia has an open capa (corrective and preventative action) to document the potential root cause and corrective actions associated with this issue.Syncardia has completed its evaluation of this complaint and is closing this file.(b)(4).

Event Description

The customer, a syncardia certified hospital, reported that the companion 2 driver exhibited a low cardiac output alarm while supporting a patient.The customer also reported that the patient began to lose consciousness, then became unresponsive and exhibited "seizure like" behavior.The customer also reported that the patient was switched to a back-up companion 2 driver and very quickly started responding and moving and is now back to normal.

• 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: michael garippa ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 6547549
• MDR Text Key: 74583146
• Report Number: 3003761017-2017-00066
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 00858000003107
• UDI-Public: (01)00858000003107
• 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,Followup
• Report Date: 04/07/2017

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: 04/10/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/04/2017
• Initial Date FDA Received: 05/05/2017
• Supplement Dates Manufacturer Received: 07/12/2017
• Supplement Dates FDA Received: 07/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/24/2012
• 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: 42 YR