MAUDE Adverse Event Report: CAREFUSION 303, INC. MAXGUARD EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	MX9171
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/29/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Second day in a row, when priming the lipid filter, rn was unable to get all the air out.Rn had to use multiple filters to find one that finally worked.Rn asked around and others were experiencing the same issue.This event did not reach the patient, as it occurred when priming the iv line prior to changing it out.I was informed by the unit senior manager, that the nurse had gone through three filters before finding one that worked.Senior manager also reported that this has been an ongoing issue for at least 3 months.If you would like, you can contact unit manager regarding this.

• Brand Name: MAXGUARD EXTENSION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION 303, INC.; 10020 pacific mesa blvd.; san diego CA 92121
• MDR Report Key: 7586332
• Report Number: 7586332
• Device Sequence Number: 2222241
• Product Code: FPA
• UDI-Device Identifier: 10885403237669
• UDI-Public: (01)10885403237669
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/30/2018
• Report Date (Section F): 05/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Nurse
• Device Expiration Date: 03/01/2023
• Device Model Number: MX9171
• Device Catalogue Number: MX9171
• Device Lot Number: 18035092
• Other Device ID Number: 1.2 MICRON FILTER AND NEEDLEL
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 05/30/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/11/2018
• 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: NO
• Date Report Sent to FDA: 05/30/2018