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

Catalog Number 397002-001

Device Problems No Apparent Adverse Event (3189); Audible Prompt/Feedback Problem (4020)

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

Event Date 07/09/2022

Event Type  malfunction  

Manufacturer Narrative

The companion 2 driver will be returned to syncardia for evaluation.The results will be provided in a follow-up mdr.

Event Description

The customer, a (b)(6) hospital, reported that the companion 2 driver exhibited a dual compressor malfunction alarm while supporting a patient.There was no reported adverse patient impact.The customer also reported that the patient was subsequently switched to a backup driver.

Manufacturer Narrative

The patient date file was reviewed and did not reveal any dual compressor malfunction alarms as reported by the customer.Per the alarm log, approximately an hour prior to the driver being removed from the patient, four very low cardiac output alarms were recorded; each alarm occurrence only lasted for a few seconds at a time.It is suspected that these are the alarms that were experienced by the customer and can occur from a low cardiac output condition such as kinking of the drivelines.The driver passed all sections of functional testing, including a 48-hour observation run with no alarms.The customer-reported dual compressor malfunction alarm could not be confirmed or reproduced.The driver performed as intended with no evidence of a device malfunction.The root cause of the customer-reported dual compressor malfunction alarm could not be conclusively determined.This issue will be tracked and trended as part of the customer complaint process.Syncardia has completed its investigation and is closing this file.Comp-(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
• Manufacturer (Section G): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• Manufacturer Contact: sagar pimpalwar ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 14987223
• MDR Text Key: 295876653
• Report Number: 3003761017-2022-00069
• Device Sequence Number: 1
• Product Code: LOZ
• 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 Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 09/07/2022

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 Catalogue Number: 397002-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/09/2022
• Initial Date FDA Received: 07/12/2022
• Supplement Dates Manufacturer Received: 07/09/2022
• Supplement Dates FDA Received: 09/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/18/2017
• 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 Age: 57 YR
• Patient Sex: Male