MAUDE Adverse Event Report: CAREFUSION ALARIS BLOOD SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	2278-0500
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product will be returned per customer.The customer complaint could not be confirmed because the product was discarded and not returned for failure investigation.The root cause of this failure was not identified.Although requested, patient demographics not provided.
Event or Problem Description
Customer reported that during an infusion there was leaking from below the upper fitment/silicone tubing connection.Although requested, no further information has been received.
Additional Manufacturer Narrative
No product was received per customer.The photo provided by the customer shows a small hole in the silicone tubing near the upper fitment.The root cause was not identified.Received from the customer was one new unopened primary set model 2278-0500 lot 18085045.No leaks, holes, tears or anomalies were noted during visual, functional, or pressure testing of the new set.
Event or Problem Description
Customer reported that during an infusion there was leaking from below the upper fitment/silicone tubing connection.Although requested, no further information has been received.

• Brand Name: ALARIS BLOOD SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8449455
• Report Number: 9616066-2019-00835
• Device Sequence Number: 11473016
• Product Code: FPA
• UDI-Device Identifier: 10885403223266
• UDI-Public: 10885403223266
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K944320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2019

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 Model Number: 2278-0500
• Device Catalogue Number: 2278-0500
• 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: 03/25/2019
• Supplement Report FDA Received Date: 06/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1