MAUDE Adverse Event Report: CAREFUSION NON-VENTED BLOOD SET

Model Number	2177-0000
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Information (3190)
Date of Event	10/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product will be returned per customer.The customer declined to return the product for failure investigation.The root cause of this failure was not identified.A: although requested, patient demographics were not provided.
Event or Problem Description
It was reported that the tubing leaked.
Additional Manufacturer Narrative
Correction; h.6.(patient code).********************************** video provided by the customer observed fluid leaking from the pvc tubing to the inlet port of the drip chamber blood filter top cap.The root cause of this failure was not identified.
Event or Problem Description
It was reported that the tubing leaked.It was further confirmed during follow up, that there was no patient harm as a result of this event.

• Brand Name: NON-VENTED BLOOD SET
• Common Device Name: BLOOD SET
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9297120
• Report Number: 9616066-2019-03142
• Device Sequence Number: 11356168
• Product Code: FPA
• UDI-Device Identifier: 07613203012652
• UDI-Public: 7613203012652
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K894842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2019

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 Expiration Date: 04/08/2022
• Device Model Number: 2177-0000
• Device Catalogue Number: 2177-0000
• Device Lot Number: 19045686
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/08/2019
• Supplement Report FDA Received Date: 01/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1