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

Model Number	2430-0500
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Ethnicity: not hispanic, african american.Concomitant medical products: 250 ml braun eva mixing container, ref: 2112528, (b)(4), lot: 37-550244.The affected product has been received and the evaluation is pending.A follow up report will be submitted once the evaluation is completed.
Event or Problem Description
It was reported that the tubing leaked from a hole underneath the upper fitment.This event occurred in the nicu, and there was no patient harm.
Event or Problem Description
It was reported that the tubing leaked from a hole underneath the upper fitment.This event occurred in the nicu.It was further confirmed during follow up, that there was no patient harm or impact as a result of this event.
Additional Manufacturer Narrative
The customer¿s report that the tubing leaked from a hole underneath the upper fitment was confirmed.The set was visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.No anomalies were observed during initial visual inspection.Functional testing found the set leaked from the top of the silicone segment.Closer inspection under a lab microscope observed that the leak is due to a small hole on the silicone segment.No tool marks or crush marks were observed on the upper fitment near the small hole.The source of the leak is due to a small hole damage in the silicone pump segment near the upper fitment.The root cause of the hole damage could not be definitively determined.

• 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: 9531676
• Report Number: 9616066-2019-03729
• Device Sequence Number: 2703870
• Product Code: FPA
• UDI-Device Identifier: 07613203011396
• UDI-Public: 7613203011396
• 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: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2019

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: 2430-0500
• Device Catalogue Number: 2430-0500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/30/2019
• Supplement Report FDA Received Date: 03/18/2020
• 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, THERAPY DATE (B)(6) 2019
• Patient Age: 1 DA
• Patient Weight: 1