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
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 tubing leaked at the upper fitment during patient use after 2 days of being in use.There was no patient harm.
Additional Manufacturer Narrative
The customer¿s report that the tubing leaked was confirmed.Visual inspection of the set showed that the silicone segment had a tear near the upper fitment measuring 0.0376 inches long.Examination under magnification showed no crush marks to the upper fitment.Functional and pressure testing confirmed leaking from the silicone tubing near the upper fitment.The root cause of the leak was a tear in the silicone segment.The cause of the tear is unknown.
Event or Problem Description
The customer reported that the tubing leaked at the upper fitment during patient use after 2 days of being in use.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: 7686859
• Report Number: 9616066-2018-00992
• Device Sequence Number: 16493387
• 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: 08/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1