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

Model Number	20029E
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/20/2018
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.Weight: (b)(6).
Event or Problem Description
The customer reported a filter leaked at "the middle part of the round filter on the back", on a patient for whom sepsis was being ruled out.Tpn was infusing through the product, as well as through the trifuse of an umbilical venous catheter.There was no patient harm.
Additional Manufacturer Narrative
Patient was an infant.The customer report of a leak at the middle part of the round filter was confirmed.Visual inspection of the as-received sample observed dried fluid residue within the filter.Functional testing identified fluid leaking from the vent of the 0.2 micron pediatric filter.The root cause of the leak was determined to be oversaturation of the filter which causes the infusate leak/weep out through the path of least resistance (filter air vent).
Event or Problem Description
It was reported a filter infusing tpn leaked at "the middle part of the round filter on the back", on an infant with respiratory distress syndrome and r/o sepsis.The tpn was infusing through a trifuse of a uvc (umbilical venous catheter).The leak was noticed quickly by the nurse; no intervention was required.Although requested, there was no additional information provided regarding this event.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: 8309587
• Report Number: 9616066-2019-00344
• Device Sequence Number: 2126970
• Product Code: FPA
• UDI-Device Identifier: 10885403234866
• UDI-Public: 10885403234866
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 12/27/2018

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: 20029E
• Device Catalogue Number: 20029E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/06/2019
• Supplement Report FDA Received Date: 03/08/2019
• 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: UMBILICAL VENOUS CATHETER,TRIFUSE,TD (B)(6) 2018; UMBILICAL VENOUS CATHETER, TRIFUSE, TD: (B)(6) 2018
• Patient Age: 8 DA