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

Model Number 397002-001

Device Problems Physical Resistance/Sticking (4012); Audible Prompt/Feedback Problem (4020)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/18/2021

Event Type  malfunction  

Manufacturer Narrative

The companion 2 driver will be evaluated by syncardia.The results will be provided in a follow-up mdr.(b)(4).

Event Description

While performing a routine servicing, a syncardia technician reported that the companion 2 driver exhibited a single compressor malfunction alarm and did not recognize external air.

Manufacturer Narrative

Alarm history data review confirmed the single compressor malfunction alarm observed during testing and there were zero external air connected notifications, at least one is expected.Visual inspection found no evidence of damage to internal or external components on the driver.Additional testing confirmed the manual pressure regulator to be the root cause of the driver not recognizing wall air.The single compressor malfunction occurred as a result of the technician not reconnecting the drivelines quickly enough; the system testing requires the operator to disconnect and reconnect the drivelines at multiple intervals to test different aspects of the system.Syncardia has a corrective and preventative action (capa) for the issue of companion 2 compressor malfunction alarm without drive lines.Corrective action to eliminate this nonconformance during system check is in process.This issue will be monitored and trended as part of the customer complaint process.Syncardia has completed its evaluation and is closing this file.If new or additional information is received in the future, syncardia will file a follow-up mdr.(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
• Manufacturer (Section G): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• Manufacturer Contact: aaron meier ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 12917367
• MDR Text Key: 282289202
• Report Number: 3003761017-2021-00224
• 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: Other
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 12/21/2022

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 Model Number: 397002-001
• Device Catalogue Number: 397002-00
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/18/2021
• Initial Date FDA Received: 12/02/2021
• Supplement Dates Manufacturer Received: 11/18/2021
• Supplement Dates FDA Received: 12/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/16/2018
• 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