MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA COMPANION DRIVER CADDY

Catalog Number	P/N 397001-001
Medical Device Problem Codes	Use of Device Problem (1670); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The companion driver caddy will be returned to syncardia for evaluation.The results will be provided in a follow-up mdr.
Event or Problem Description
The customer, a syncardia certified hospital, reported that a c2 driver was stuck in the caddy - they can't press in the lock button to remove the driver.States driver is seated properly in the caddy groove.Email later received that biomed was finally able to remove the driver from the caddy, but they are requesting to send it back to be checked out.
Additional Manufacturer Narrative
Device history record (dhr) review confirmed that companion caddy s/n ca09000340 was serviced and passed all functional teting prior to being released to finished goods.Visual inspection of internal and external components found no abnormalities.Companion caddy passed all functional testing for acceptance at incoming inspection.An addtiional driver docking test was performed with the driver docked and then undocked ten times.No fault or issue was observed during this testing.Complaint was unable to be replicated.Failure investigation for this complaint confirmed the reported issue from the photos provided with the initial complaint.The customer complaint was not replicated during testing; the root cuase of the reported malfunction of the caddy to undock the driver was unable to be determined.Failure investigation identified no test failures or damage that could have contributed to the complaint.No evidence of a device malfunction was found.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.
Event or Problem Description
The customer, a (b)(6) hospital, reported that a c2 driver was stuck in the caddy - they can't press in the lock button to remove the driver.States driver is seated properly in the caddy groove.Email later received that biomed was finally able to remove the driver from the caddy, but they are requesting to send it back to be checked out.

• Brand Name: SYNCARDIA COMPANION DRIVER CADDY
• Common Device Name: COMPANION DRIVER CADDY
• 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: maia kirk ; 1992 e silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 17408390
• Report Number: 3003761017-2023-00106
• Device Sequence Number: 7121476
• Product Code: LOZ
• UDI-Device Identifier: 00858000003145
• UDI-Public: (01)00858000003145
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P030011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: P/N 397001-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/18/2023
• Supplement Date Received by Manufacturer: 07/18/2023
• Initial Report FDA Received Date: 07/27/2023
• Supplement Report FDA Received Date: 07/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/12/2010
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown