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
The affected product has been received and the evaluation is pending.A follow up report will be submitted once the evaluation is completed.Patient age and dob requested but not provided, however, the event reportedly occurred in the special care nursery, 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.
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 nurse describes the tubing set-up as follows; the bd alaris pump infusion burette set, attach a maxzero to the tubing set, spike the fluid with iv tubing set, prime tubing with fluids though maxzero, prime lipid port with lipids, prime medication port with normal saline, place the tubing set into the alaris pump and connect to the patient's central line.When the tubing set occludes, the rn has to "break the line" in order to continue the infusion, which the customer further stated that this increases the risk for infection to the infant patient.The customer further stated that there were no adverse effects caused to the infant patient from the event.
Additional Manufacturer Narrative
Central line; non-bd curos alcohol cap.The customer¿s report that the tubing set occludes was confirmed.The set was visually inspected for kinks, holes/tears in the tubing or damages to the components.Visual inspection of the set noted dried fluid residue within the two filters.No other obvious issues or damages were observed.Functional testing confirmed slight resistance when pushing fluid through the two tubings which had the filters.However, the fluid was able to exit the set as expected.The probable cause was that the set's filters can become clogged after prolonged exposure as well as viscous fluid being inhibited when passing through the filter.The root cause of the customer¿s report was not identified.

• 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: 9234809
• Report Number: 9616066-2019-02980
• Device Sequence Number: 11383605
• 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,Followup
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/24/2019
• Supplement Report FDA Received Date: 12/23/2019
• 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: 8100,8015,PRI TUBING, THERAPY DATE UNK