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

Model Number	20029E
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected product has been received and the evaluation is pending.A follow up report will be submitted once the evaluation is completed.
Event or Problem Description
It was reported that the iv tubing set leaked during an infusion of tpn on a premature baby.There was crystallization on the outside of the filter which appeared it was leaking for an extended period.There was no patient impact.
Additional Manufacturer Narrative
Additional information added; section; b.5.(patient/event information clarified/detailed), d.11, & h.6.(device code).The customer¿s report of a filter leak was confirmed.The set configuration was visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.No anomalies were observed with set and components during initial visual inspection.Functional infusion testing found a leak from the air vent of the micron filter.The root cause of the leak could not be definitively determined.
Event or Problem Description
It was reported that the iv tubing set leaked during an infusion of tpn on a premature baby.Filter was cracked and there was crystallization on the outside of the filter which appeared it was leaking for an extended period.It was confirmed during follow up that there was no delay in patient care, and that this event did not contribute to, or result in a serious adverse impact to patient.

• Brand Name: ALARIS EXTENSION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9831766
• Report Number: 9616066-2020-00764
• Device Sequence Number: 2421333
• Product Code: FPA
• UDI-Device Identifier: 10885403234866
• UDI-Public: 10885403234866
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K960280
• 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): 02/17/2020

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: 20029E
• Device Catalogue Number: 20029E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/13/2020
• Supplement Report FDA Received Date: 06/18/2020
• 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: 500ML EVA MIXING CONTAINER,TD(B)(6) 2020; 8015, 8100, 2420-0007
• Patient Age: 14 DA
• Patient Weight: 1