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

Model Number	MS3500
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected device 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 there was a hole noticed in the secondary tubing set causing an unspecified fluid to leak onto the nurse while priming.This occurred in oncology.There was no patient involvement.
Event or Problem Description
It was reported that there was a hole noticed in the secondary tubing set causing an unspecified fluid to leak onto the nurse while priming.This occurred in oncology.There was no patient involvement.
Event or Problem Description
It was reported that there was a hole noticed in the secondary tubing set causing an unspecified fluid to leak onto the nurse while priming.This occurred in oncology.There was no patient involvement.
Additional Manufacturer Narrative
Additional information provided: d.4 & h.4 the customer's report of a hole in the tubing set causing a leak was confirmed.The set was inspected for kinks, holes/tears in the tubing, or damages to the components.Visual inspection of the set noted a tear in the approximately 1/4 inches below the drip chamber component.The tear was measured as approximately 0.06 inches in length.Further inspection around the tubing area observed an abrasion on the opposite side of the tear.Functional and pressure testing confirmed fluid slightly leaking out from the tear.The cause of the leak was due to the observed tubing tear.The root cause of the observed damage was not identified.The device history record for set model ms3500 lot 20013378 shows the set was manufactured on 23jan2020 with a total of (b)(4) units.There were no quality notifications issued during the production build of this set.

• Brand Name: ALARIS SECONDARY SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 10114225
• Report Number: 9616066-2020-01839
• Device Sequence Number: 2115468
• Product Code: FPA
• UDI-Device Identifier: 10885403222603
• UDI-Public: 10885403222603
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K051499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/12/2020

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: 01/23/2023
• Device Model Number: MS3500
• Device Catalogue Number: MS3500
• Device Lot Number: 20013378
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 06/03/2020
• Supplement Report FDA Received Date: 06/08/2020; 08/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1