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

Catalog Number P/N 397002-001

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Hemolysis (1886)

Event Date 12/04/2022

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 report.

Event Description

The customer, a syncardia authorized distributor, reported the patient is experiencing strong hemolysis.The current parameters are bpm 120, % syst.50, left pressure 180, right pressure 80, left vacuum -5, right vacuum -4, with an abnormal right pressure slope (steep).Several imaging techniques were used to see if there were any kinks in the outflow grafts.No kinks were observed.Patient was switched to a back-up driver.After further investigation, the patient's clinical team is indeed now suspecting chronic myeloid leukemia, which they are currently exploring.

• 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: 16062217
• MDR Text Key: 306813526
• Report Number: 3003761017-2022-00137
• Device Sequence Number: 1
• Product Code: LOZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: P/N 397002-001
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/07/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/18/2018
• 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
• Patient Age: 62 YR
• Patient Sex: Male