MAUDE Adverse Event Report: CAREFUSION ALARIS® PUMP MODULE ADMINISTRATION SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	10879047
Medical Device Problem Code	Backflow (1064)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Unable to determine the cause of the customer's reported complaint because the set has been discarded by the customer and will not be returned.The root cause of this failure could not be identified.Ethnicity: not hispanic/latino.
Event or Problem Description
Customer advocacy received a copy of the customer's maude report from the fda which states, "back check valve failed on the primary bd alans pump infusion set primary was set up and running when rn hooked up the secondary to run iv antibiotic (primary was on extender and secondary was hung high) the entire bag flowed into the primary back.Rn contacted the provider and gave the entire 500 ml bag with antibiotic to the patient." an incomplete date of event of(b)(6) 2019 was provided.

• Brand Name: ALARIS® PUMP MODULE ADMINISTRATION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9145533
• Report Number: 9616066-2019-02742
• Device Sequence Number: 19497329
• Product Code: FPA
• UDI-Device Identifier: 10885403232275
• UDI-Public: 10885403232275
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K944320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/06/2019

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: 04/18/2022
• Device Model Number: 10879047
• Device Catalogue Number: 10879047
• Device Lot Number: 19046497
• 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: 10/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 23 YR