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

Model Number	MX9166
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The devices have been received and the evaluation is pending.A follow up report will be submitted with investigation results once the evaluation has been completed.There was no patient harm.Patient demographics, requested but not provided.
Event or Problem Description
It was reported that; during a tpn infusion there was a leak from the air-eliminating filter.There were 2 occurrences, using 2 separate filters, with the same lot number.The filtered leaked from the back side of the built-in "circle area".Both incidents involved the same patient, on the first occurrence, the filter was attached for approximately 10 hours and on the 2nd it was attached for 6 hours.There was no patient harm.
Additional Manufacturer Narrative
The customer¿s report that there was a leak from the air-eliminating filter was confirmed.The sets were visually inspected for obvious damage such as cracks, kinks, holes, and tears in the tubing and their components.No anomalies or evidence of damage were observed on the filters or the sets upon visual inspection.Functional testing was performed and small droplets were immediately observed leaking from the 0.2 micron filter¿s air vent (termed ¿weeping out¿), confirming the customer¿s report of a leak at the air-eliminating filter.No other leaks were observed the root cause of the leak was not identified.Although the root cause was not definitively determined, the probable identified cause of the observed filter vent leak was due to clog/oversaturation of the filter and the time of use from which the fluid flow was restricted.
Event or Problem Description
It was reported that during a tpn infusion there was a leak from the air-eliminating filter.There were 2 occurrences, using 2 separate filters, with the same lot number.The filtered leaked from the back side of the built-in "circle area".Both incidents involved the same patient.On the first occurrence, the filter was attached for approximately 10 hours and on the second occurrence, it was attached for 6 hours.It was confirmed there was no patient harm.

• Brand Name: EXTENSION SET
• Common Device Name: SET,EXTENSION,INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9177534
• Report Number: 9616066-2019-02846
• Device Sequence Number: 11453982
• Product Code: FPA
• UDI-Device Identifier: 10885403237652
• UDI-Public: 10885403237652
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K051499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2019

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 Expiration Date: 01/30/2024
• Device Model Number: MX9166
• Device Catalogue Number: MX9166
• Device Lot Number: 19017181
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/10/2019
• Supplement Report FDA Received Date: 10/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1