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

Model Number	10012283
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: picc line (1.9 and 1.2 fr); 24 gauge iv catheters.The affected product has been received and the investigation is pending.A follow up report will be submitted once the failure investigation has been completed.The event reportedly occurred in the nicu; therefore it is presumed the patient was a neonate.Requested, however not provided.
Event or Problem Description
It was reported that tpn(250ml) leaks around the filter.The customer stated that the nicu neonates have either picc or iv lines that are mate to tpn tubing to a trifuse for 20% intralipids and antibiotics infusions.The tpn rates varied from 5-12 ml/hr.The rn stated tubing was primed and hung/primed on september 30th and was noted to be leaking from the tpn filter on 10/2.There was no obvious signs of harm to the patient however a potential risk of infection.Although requested, no further details were provided by the customer for this event.
Additional Manufacturer Narrative
The customer¿s report of a leak around the filter was confirmed during functional testing.It was observed that fluid leaked out (termed ¿weeping out¿) from the bottom vent of the primary set¿s micron adult filter.The set was visually inspected for obvious damage such as cracks, kinks, holes, and tears in the tubing and its components.Light yellow liquid was observed within the micron filter and throughout the set.Moldy residue was also observed on the top filter vent¿s membrane.Sticky residue was noted on the surface of the set¿s filter.No anomalies or evidence of damage were observed on the filters or the sets upon visual inspection.Functional testing was performed by spiking the primary set to one lab iv bag filled with water confirming the customer¿s report of a leak.No other leaks were observed.The root cause was not identified.
Event or Problem Description
It was reported that (tpn) (250ml) leaks around the filter.The customer stated that the (nicu) neonates have either picc or iv lines that are mate to tpn tubing to a trifuse for 20% intralipids and antibiotics infusions.The tpn rates varied from 5-12 ml/hr.The rn stated the tubing was primed and hung/primed on september 30th and was noted to be leaking from the tpn filter on 10/2.There was no obvious signs of harm to the patient, however; there is a potential risk of infection.Although requested, no further details were provided by the customer for this event.

• Brand Name: ALARIS EXTENSION SET
• Common Device Name: SET, EXTENSION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9281391
• Report Number: 9616066-2019-03083
• Device Sequence Number: 18937113
• Product Code: FPA
• UDI-Device Identifier: 10885403233692
• UDI-Public: 10885403233692
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K944320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/02/2021
• Device Model Number: 10012283
• Device Catalogue Number: 10012283
• Device Lot Number: 18035035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/05/2019
• Supplement Report FDA Received Date: 12/30/2019
• 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: 20038E,PRI TUBING,8015,(2)8100,TD UNK.