MAUDE Adverse Event Report: CAREFUSION ALARIS INFUSION SET; SET, INFUSION, INTRAVASCULAR

Model Number	11612593
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: non-bd extension set; non-bd access bag; spiros connectors, therapy date (b)(6) 2018.The affected product has been received and the investigation is pending.A follow up report will be submitted once the failure investigation has been completed.
Event or Problem Description
The customer reported that the filter was in use for less than 24 hours when it leaked while infusing maintenance fluids.There was no patient harm.
Additional Manufacturer Narrative
Concomitant medical products: (3)spiros caps.The customer¿s report of a leaking filter was confirmed.Visual inspection of the set did not reveal any discernible damage or abnormalities.Functional testing confirmed leaking from the upper vent hole on the filter.Inspection under magnification of the leaking component did not reveal any noticeable damage to either the filter membrane or housing.The root cause of the leaking was not determined.
Event or Problem Description
The customer reported that the filter was in use for less than 24 hours when it leaked while infusing maintenance fluids.There was no patient harm.

• Brand Name: ALARIS INFUSION SET
• Common Device Name: SET, INFUSION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 7687031
• Report Number: 9616066-2018-00993
• Device Sequence Number: 19182057
• Product Code: FPA
• UDI-Device Identifier: 10885403283963
• UDI-Public: 10885403283963
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K970485
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2018

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: 11612593
• Device Catalogue Number: 11612593
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2018
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/13/2018
• Supplement Report FDA Received Date: 08/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 8100,8015, THERAPY DATE (B)(6) 2018; NON-BD BAG ACCESS DEVICE,NON-BD BI-FUSE SET