MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA COMPANION 2 DRIVER HAND PUMP

Catalog Number	397004-001
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Hand pump has large hole in the side casing.It appears to be fully functional but site is not comfortable using it on a patient due to the damage.
Additional Manufacturer Narrative
Device history record (dhr) review confirmed that hand pump s/n (b)(6) was serviced and passed all functional testing prior to being released to finished goods.Visual inspection of external components found an orifice on the side of the hand pump body.Device passed all areas of functional testing for acceptance at incoming inspection.Physical damage did not impact functionality of the driver.Failure investigation for this complaint confirmed te reported issue.The customer complaint was replicated during testing, confirming the hand pump was still functional although it was visibly damaged.Root cause of the damage sustained while in the field was unable to be determined.Failure investigation identified no other test failures or damage that could have contributed to the reported issue.Damage was sustained after hand pum was nsite with the customer and was investigated for functionality at customer request.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.
Event or Problem Description
Hand pump has large hole in the side casing.It appears t be fully functional but site is not comfortable using it on a patient due to the damage.

• Brand Name: SYNCARDIA COMPANION 2 DRIVER HAND PUMP
• Common Device Name: HAND PUMP
• 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: 19082433
• Report Number: 3003761017-2024-00075
• Device Sequence Number: 15393463
• Product Code: LOZ
• UDI-Device Identifier: 00858000003114
• UDI-Public: (01)00858000003114
• 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): 08/08/2024

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: 397004-001
• 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: 04/03/2024
• Supplement Date Received by Manufacturer: 04/03/2024
• Initial Report FDA Received Date: 04/10/2024
• Supplement Report FDA Received Date: 08/08/2024
• 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