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

Catalog Number P/N 397002-001

Device Problems Output Problem (3005); Appropriate Term/Code Not Available (3191)

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

Event Date 05/16/2023

Event Type  malfunction  

Manufacturer Narrative

The companion 2 driver will be further investigated by syncardia.The results will be provided in a follow-up mdr.

Event Description

During routine evaluation, a syncardia service technician reported that the companion 2 driver has a very low cardiac output of 1.1 as well as a high reading on the left driver pressure.Driver also switches to the second compressor once the driver is turned on.

Event Description

During routine evaluation, a syncardia service technician reported that the companion 2 driver has a very low cardiac output of 1.1 as well as a high reading on the left driver pressure.Driver also switches to the second compressor once the driver is turned on.

Manufacturer Narrative

Device history record (dhr) review confirmed that companion 2 driver s/n (b)(6) was serviced and passed all functional testing prior to being released to finished goods.Alarm history and patient data file review found multiple alarms indicating "very low left pressure." visual inspection of external components found no abnormalities.Visual inspection of internal components found damage to capacitor.Driver failed functional testing for acceptance at incoming inspection due to out of range cardiac output and high left driveline pressure.Additional testing concluded the excessive left driveline pressure was due to the left driveline transducer on sensor board.A known functional sensor board was installed and driver passed all functional testing without alarm or malfunction.Failure investigation for this complaint confirmed the reported issue.The customer complaint was replicated during testing; root cause of the reported out of range outputs and system check failure was due to a faulty pressure sensor board.Failure investigation identified no other test failures or damage that could have contributed to the complaint.Damage found to the capacitor was cosmetic only.Device was not in patient use at time of complaint.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.

• 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: 17005579
• MDR Text Key: 316283210
• Report Number: 3003761017-2023-00082
• 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,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 04/18/2024

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 Catalogue Number: P/N 397002-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2023
• Initial Date Manufacturer Received: 05/16/2023
• Initial Date FDA Received: 05/25/2023
• Supplement Dates Manufacturer Received: 05/16/2023
• Supplement Dates FDA Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/17/2018
• 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