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 Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.Patient demographics requested however not provided.
Event or Problem Description
The set was received as an unexpected return with a report that the set leaked lipids.A note received with the product that stated:" leaking when all the lines met together".Although requested, no further details were provided by the customer for this event.
Event or Problem Description
The set was received as an unexpected return with a report that the set leaked lipids.A note received with the product that stated:" leaking when all the lines met together".Although requested, no further details were provided by the customer for this event.Upon investigation of the set received a leak was noted however the set did not a contain a white substance inside of the set.
Additional Manufacturer Narrative
The set was received as an unexpected return with a report that the trifuse set leaked.The noted leak issue 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 water to one of the maxzero valves connected to one of the set¿s three female luer ports and the fluid was attempted to be pushed through.It was observed that there was a fluid leak at the engagement between one of the three tubing's to the parallel connector¿s component.Fluid was attempted to be pushed through the rest of the ports and a leak was observed at the same engagement.The root cause was identified as a sink condition in the parallel connector component (supplier issue).

• 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: 8532489
• Report Number: 9616066-2019-01075
• Device Sequence Number: 19294353
• Product Code: FPA
• UDI-Device Identifier: 10885403236112
• UDI-Public: 10885403236112
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K051499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2019

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: ME1224
• Device Catalogue Number: ME1224
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/19/2019
• Supplement Report FDA Received Date: 07/22/2019
• 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: PRI TUBING, (3)MZ1000-07,THERAPY DATE UNKNOWN; PRI TUBING, (3)MZ1000-07,THERAPY DATE UNKNOWN