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

Model Number	MZ9325
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product will be returned.The customer¿s complaint could not be confirmed because the product will not be returned for failure investigation.The root cause of this failure was not identified.Patient age and dob requested but not provided, however, the event reportedly occurred in the special care nurse, therefore the patient is presumed to be an infant.
Event or Problem Description
The customer reported that the maxzero tri-fuse tubing set occludes during a lipid infusion while in use in the special care nursery.The rn has to "break the line" in order to continue the infusion.The customer further stated that there were no adverse effects caused to the patient from the event.

• 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: 9234811
• Report Number: 9616066-2019-02979
• Device Sequence Number: 16702674
• Product Code: FPA
• UDI-Device Identifier: 10885403427244
• UDI-Public: 10885403427244
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K140831
• 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
• Report Date (Section B): 10/01/2019

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: 01/22/2022
• Device Model Number: MZ9325
• Device Catalogue Number: MZ9325
• Device Lot Number: 19016609
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1