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

Model Number 397002-001

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemolysis (1886)

Event Date 09/28/2021

Event Type  Injury  

Manufacturer Narrative

The companion 2 driver will be returned to syncardia for evaluation.The results will be provided in a follow-up mdr.(b)(4).

Event Description

The customer, a syncardia authorized distributor, reported that the patient developed hemolysis (ldh approximately 3000 u/l and fresh hemoglobin approximately 200 mg/dl) while supported by the companion 2 driver.The customer also reported the patient was subsequently switched to a backup companion 2 driver and the ldh decreased and the free hemoglobin returned to normal levels.

Manufacturer Narrative

The patient data file was reviewed and showed that driver was put on patient support on (b)(6) 2021 at 0209.The driver ran for 42 days until on (b)(6) 2021 at 1036 when patient was switched to a different driver.During this time frame there were no recorded alarms that would indicate a device malfunction that could have contributed to the patient hemolysis.During review of the patient file data, it was also possible to graph out what the pressure and flow waveforms would have looked like on the companion 2 driver display during patient use.The pressure and flow waveforms of the first and last hours of patient use were reviewed and showed no evidence of a device malfunction.During functional testing, the driver passed all test steps.The driver was further subjected to an additional 48-hour observation run in an attempt to observe a possible malfunction or change in driver performance.The driver performed as intended, and there was no evidence of a device malfunction.The customer-reported patient hemolysis caused by a possible device malfunction was unable to be confirmed.The root cause of the customer-reported patient hemolysis could not be determined.Syncardia is aware that all mechanical circulatory support devices may contribute to hemolysis and is continuing to study the impact of the tah-t system on the reported experience.Syncardia has completed its investigation and is closing this file.(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: sagar pimpalwar ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 12673425
• MDR Text Key: 277693241
• Report Number: 3003761017-2021-00199
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 00858000003107
• UDI-Public: (01)00858000003107
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 09/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2021
• 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 Manufacturer Received: 09/29/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/04/2018
• 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 Outcome(s): Required Intervention
• Patient Age: 45 YR
• Patient Sex: Prefer Not To Disclose