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

Model Number	21028E
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: 250ml baxter eva container, exp: 10/21/19, 0.9% sodium chloride injection; spiros adapter.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 during an infusion, the rn was attempting to hang etoposide as the primary infusion when she noticed that the outside of the filter was full of air and wet.There was no patient impact.
Event or Problem Description
It was reported that during an infusion, the rn was attempting to hang etoposide as the primary infusion when it was noticed that the outside of the filter was full of air and wet.It was confirmed during follow up, that there was no patient harm as a result of this event.
Additional Manufacturer Narrative
Additional information added; d.11.Correction to sections: d.1, d.4, d.11, (omit 21028e), & g.5.The customer¿s report that the outside of the filter was full of air and wet was confirmed on the extension set received.The sets were visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.Clear liquid was observed in the primary set¿s drip chamber and the entire length of tubing of both sets.Visual inspection observed no damage to the filter¿s membrane or housing.Functional testing observed leaking out of the filter vent closest to the outlet port on the extension set¿s micron filter.Although the root cause was not definitively determined, the probable identified cause of the observed filter vent leaking and ingress of air was due to clog/oversaturation of filter and the time of use from which the fluid flow was restricted.The fluid then seeks the path of least resistance through the filter vent.

• Brand Name: SMARTSITE® EXTENSION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9322881
• Report Number: 9616066-2019-03284
• Device Sequence Number: 2233235
• Product Code: FPA
• UDI-Device Identifier: 07613203021210
• UDI-Public: 7613203021210
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,distri
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2019

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 Model Number: 21028E
• Device Catalogue Number: 21028E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/14/2019
• Supplement Report FDA Received Date: 02/06/2020
• 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: 10013072; 21028E, THERAPY DATE (B)(6) 2019