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

Model Number	MZ9271
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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
The customer reported fluid leaked at uac junction.The uac was discontinued.There was no report of patient harm.
Event or Problem Description
The customer reported fluid leaked at uac junction.The uac was discontinued.There was no report of patient harm.
Additional Manufacturer Narrative
The customer¿s report that the tubing fluid leaked at the uac junction was confirmed.Functional pressure testing was able to confirm a leak from the suspect maxzero female port.Closer inspection of the maxzero under magnification observed a microchannel on the interior maxzero walls that allowed fluid to leak.The cause of the leak is a microchannel found in the maxzero component.The root cause of the microchannel which creates a fluid path is a manufacturing issue.
Event or Problem Description
The customer reported fluid leaked at uac junction.The uac was discontinued.There was no report of patient harm.

• Brand Name: MAXZERO EXTENSION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 7748787
• Report Number: 9616066-2018-01247
• Device Sequence Number: 1793475
• Product Code: FPA
• UDI-Device Identifier: 10885403240744
• UDI-Public: 10885403240744
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K140831
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/13/2018

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: MZ9271
• Device Catalogue Number: MZ9271
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2018
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 08/03/2018
• Supplement Report FDA Received Date: 08/16/2018; 10/29/2018
• 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: MZ9265; MZ9271,MZ9265, TD (B)(6) 2018
• Patient Age: 2 MO