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

Model Number	MS3500
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no patient involvement.The customer's complaint that the tubing separated from the bottom of the chamber was confirmed.A photo provided by the customer observed that the tubing was separated from the drip chamber outlet port.Without return of the device for investigation, the root cause of this failure could not be identified.
Event or Problem Description
It was reported that the nurse had just removed the iv tubing set from the package.The iv bag was spiked with the set, and when the nurse squeezed the drip chamber to prime the set, the tubing separated from the bottom of the drip chamber.The event occurred during priming; there was no patient involvement.

• Brand Name: ALARIS® SECONDARY ADMINISTRATION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9135595
• Report Number: 9616066-2019-02736
• Device Sequence Number: 3123534
• Product Code: FPA
• UDI-Device Identifier: 10885403222603
• UDI-Public: 10885403222603
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• 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: 02/26/2022
• Device Model Number: MS3500
• Device Catalogue Number: MS3500
• Device Lot Number: 19026708
• 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: 09/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1