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

Model Number	2452-0007
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected product has been received and the investigation is pending.A follow up report will be submitted once the failure investigation has been completed.
Event or Problem Description
It was reported that the tubing set separated at the middle y-site when priming a 1l normal saline bag.This occurred on 2 north.There was no patient involvement.
Additional Manufacturer Narrative
The customer¿s report that the tubing set separated at the middle y-site was confirmed.The set was visually inspected for kinks, holes/tears in the tubing or damages to the components.Visual inspection observed that the set was separated at the engagement between the tubing to second smartsite¿s inlet port.Closer inspection of the separation under a lab microscope observed that the tubing had an insufficient solvent applied at the engagement during manufacturing process.A dimensional analysis was performed and the tubing¿s outer diameter was measured and found to be within specification.Functional testing could not be performed due to the separation at the engagement.A device history record for model 2452-0007 with lot number 19087864 was performed.The search showed that a total of (b)(4) units were built in 1 lot on 29aug2019.The search showed that there were no quality notifications for the failure mode reported by the customer.The root cause of the separation was identified as a manufacturing issue for insufficient solvent being applied at the engagement of the tubing due to equipment and/or operator error.
Event or Problem Description
It was reported that the tubing set separated at the middle y-site when priming a 1l normal saline bag.This occurred on 2 north.There was no patient involvement.

• 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: 9944573
• Report Number: 9616066-2020-01303
• Device Sequence Number: 3070749
• Product Code: FPA
• UDI-Device Identifier: 10885403219870
• UDI-Public: 10885403219870
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K944320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2020

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: 08/29/2022
• Device Model Number: 2452-0007
• Device Catalogue Number: 2452-0007
• Device Lot Number: 19087864
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/09/2020
• Supplement Report FDA Received Date: 07/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1