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

Catalog Number	397001-001
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Perfusionist reported to clinical on site that extra caddy they have has a broken latch - will not push down.
Event or Problem Description
Perfusionist reported to clinical on site that extra caddy they have has a broken latch - will not push down.
Additional Manufacturer Narrative
Device history record (dhr) review confirmed that companion caddy s/n (b)(6) was serviced and passed all functional testing prior to being released to finished goods.Visual inspection of external and internal components found no abnormalities.Companion caddy failed functional testing for acceptance at incoming inspection due to broken latch that prevented driver from being removed without assistance.The release plunger assembly did not operate as intended, confirming the reported complaint.Additionally, the plunger assembly was missing lubrication necessary for normal functionality.A known functional release plunger assembly was installed and caddy performed as intended.Failure investigation for this complaint confirmed the reported issue during functional testing.The customer complaint was replicated during testing; the root cause of the reported broken latch was determined to be missing lubrication in the release plunger assembly.Failure investigation identified no test failures or damage that could have contributed to the event.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 DRIVER CADDY
• Common Device Name: COMPANION 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: michael larsen ; 1992 e silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 18400829
• Report Number: 3003761017-2023-00180
• Device Sequence Number: 14128149
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2024

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: 397001-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/19/2023
• Supplement Date Received by Manufacturer: 12/19/2023
• Initial Report FDA Received Date: 12/27/2023
• Supplement Report FDA Received Date: 11/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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