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

Model Number	10933805
Medical Device Problem Code	Failure to Prime (1492)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The devices have been received and the evaluation is pending.A follow up report will be submitted with investigation results once the evaluation has been completed.
Event or Problem Description
Customer advocacy received a copy of the customer's medwatch report from the fda which states, "intravenous tubing would not prime." an incomplete date of event of (b)(6) 2019 was provided.It was reported that the event occurred in pediatric icu (picu).There was no delay in patient therapy.
Additional Manufacturer Narrative
The customer¿s medwatch report of intravenous tubing that would not prime was confirmed.Visual inspection observed that the set's check valve was in its correct location on the set but was upside down.Clear liquid was observed in the set¿s drip chamber and the first twenty inches of tubing.Functional gravity testing was met with an occlusion due to the upside down check valve component.The root cause of the incorrectly installed check valve was due to a manufacturing assembly error.The set was visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.Functional testing was performed by filling a lab iv bag with blue-dyed water and attaching the returned used disposable set allowing fluid to flow through the set via gravity.It was observed that the set would not prime past the check valve.The root cause was due to a manufacturing assembly error.
Event or Problem Description
Customer advocacy received a copy of the customer's medwatch report from the fda which states, "intravenous tubing would not prime." an incomplete date of event of xx-(b)(6) 2019 was provided.It was reported that the event occurred in pediatric icu (picu).There was no delay in patient therapy.

• 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: 9200375
• Report Number: 9616066-2019-02916
• Device Sequence Number: 3146759
• Product Code: FPA
• UDI-Device Identifier: 07613203019088
• UDI-Public: 7613203019088
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2019

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 Model Number: 10933805
• Device Catalogue Number: 10933805
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/16/2019
• Supplement Report FDA Received Date: 12/30/2019
• 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: 10ML SYRINGE, TD (B)(6) 2019.