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

Model Number	ME1224
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although requested, product has not been received.A follow up report will be submitted with failure investigation results should the product be received for evaluation.Although requested, patient demographics not provided.
Event or Problem Description
It was reported that in the anesthesia department, a tri-fuse set leak when used.Although requested, no further information has been received.
Additional Manufacturer Narrative
Additional information added to: the customer¿s report of a tri-fuse set leak was confirmed.A leak was observed at the engagement between the tubing and 4-way parallel connector components.Functional testing was performed by connecting a lab syringe filled with blue dye fluid to each one of the set¿s three female luer ports.The syringe plunger was depressed and no leaks were observed after flushing through each of the ports.A stopcock in the closed position was connected to the set's male luer end.After flushing through each of the ports, a leak was observed at the same engagement between one of the three tubing's to the 4-way parallel connector regardless of which port was being flushed.The set was also pressure tested while submerged underwater.With the air introduced through each of the ports, a leak was immediately observed from the same earlier noted engagement at around 1psi.With air pressure incrementally increased to 30psi, no other leaks were observed from anywhere else.The root cause was a sink condition in the parallel connector component (supplier issue).
Event or Problem Description
It was reported that in the anesthesia department, a tri-fuse set leaked when used.Although requested, no further information has been received.

• Brand Name: MAXGUARD EXTENSION SET
• Common Device Name: SET,ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8482859
• Report Number: 9616066-2019-00914
• Device Sequence Number: 1576563
• Product Code: FPA
• UDI-Device Identifier: 10885403236112
• UDI-Public: 10885403236112
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K051499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2019

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: 08/24/2022
• Device Model Number: ME1224
• Device Catalogue Number: ME1224
• Device Lot Number: 17087486
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/04/2019
• Supplement Report FDA Received Date: 07/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1