MAUDE Adverse Event Report: CAREFUSION ALARIS® SYRINGE MODULE SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	10014916
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: 8015; 10014916; (2)mz1000-07; (2)spm tubing; (2)8110; (2)non bd 12ml syringe with a 3ml label lot 180930-010 exp 10/02/2018 0.45% sodium chloride flush; therapy date: (b)(6) 2018.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
The customer reported during a fentanyl and dopamine infusion, a leak was noted below both 0.2 micron filters on the extension sets.It was reported by the clinician that both sets were new when the leak occurred.There was no report of patient harm.The event occurred n picu.
Additional Manufacturer Narrative
The customer's report of a leak was confirmed.Functional testing showed that fluid was leaking from the engagement between the outlet port of the filter and the microbore tubing component.Further inspection showed that the tubing was not fully bonded to its mated filter component.The root cause of the leak was a manufacturing assembly issue of insufficient solvent application at the engagement.
Event or Problem Description
The customer reported during a fentanyl and dopamine infusion, a leak was noted below both 0.2 micron filters on the extension sets.It was reported by the clinician that both sets were new when the leak occurred.There was no report of patient harm.The event occurred in picu.

• Brand Name: ALARIS® SYRINGE MODULE SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8001965
• Report Number: 9616066-2018-02036
• Device Sequence Number: 427935
• Product Code: FPA
• UDI-Device Identifier: 10885403233920
• UDI-Public: 10885403233920
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K811885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2018

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 Expiration Date: 05/23/2021
• Device Model Number: 10014916
• Device Catalogue Number: 10014916
• Device Lot Number: 18057691
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2018
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/24/2018
• Supplement Report FDA Received Date: 12/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 5 YR
• Patient Weight: 18