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

Catalog Number	397001-001
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During routine evaluation, a syncardia technician reported the companion caddy failed incoming functional testing due to no voltage output.
Additional Manufacturer Narrative
The companion caddy will be evaluated and the results provided in a follow-up mdr.
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 out of specification voltages across connector pins.Additional testing included opening the caddy chassis to troubleshoot the voltage issue.The investigation found that the external power supply was not activating when plugged from a wall power source and observational testing found a broken piece of hardware that eventually separated completely from the main component.External power supply components are assembled at a different site so further testing into the integrity of the component is not available at this time.A known functional power supply was installed and the device functioned without issue with the replacement.Customer complaint could not be replicated.Failure investigation for this complaint confirmed the reported issue through functional testing.The specific customer complaint could not be replicated; the root cause of the out of specification voltage was determined to be a broken piece within the external power supply.Failure investigation identified no other test failures or damage that could have contributed to the complaint.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
During routine evaluation, a syncardia technician reported the companion caddy failed incoming functional testing due to no voltage output.

• 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: aaron meier ; 1992 e silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 17191625
• Report Number: 3003761017-2023-00090
• Device Sequence Number: 15293684
• Product Code: LOZ
• UDI-Device Identifier: 00858000003145
• UDI-Public: (01)00858000003145
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Other
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2024

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: Other
• Device Catalogue Number: 397001-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/12/2023
• Supplement Date Received by Manufacturer: 06/12/2023
• Initial Report FDA Received Date: 06/23/2023
• Supplement Report FDA Received Date: 06/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/12/2013
• 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