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

Model Number	MS3500
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/05/2019
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 at the completion of a secondary infusion, the iv tubing set leaked from the secondary junction while connected to the secondary part of the maintenance line.The connection was tight and no crack was noted.There was no patient impact.
Event or Problem Description
It was reported that at the completion of ceftolozane/tazobactam1,000mg in 100ml ns secondary infusion, a leak was observed at the connection between secondary and primary sets.Potassium chloride 20meq was infusing through the primary set.It was noted that the connection between two sets was tight and no crack was seen.It was further confirmed during follow up, that there was no patient harm or impact as a result of this event.
Event or Problem Description
It was reported that at the completion of a secondary infusion, the iv tubing set leaked from the secondary junction while connected to the secondary part of the maintenance line.The connection was tight and no crack was noted.It was further confirmed during follow up, that there was no patient harm or impact as a result of this event.
Additional Manufacturer Narrative
Additional information; section; b.5.(patient/event information clarified/detailed) the customer¿s report that the set leaked at the connection between the primary and secondary set was not confirmed.The sets in their as received configuration were visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.Visual inspection of the set noted no damage or any anomalies.Functional testing resulted in fluid flowing freely through both the primary and secondary set with no signs of leaking at the connection or anywhere else throughout the sets.The sets in their as received configuration were loaded into a lab pump module for an infusion test.The primary and secondary infusions were programmed and both primary and secondary infusions completed with no leaks at the connection or anywhere else throughout the sets.Pressure testing resulted in no air entering the line anywhere on the set while the tubing was manipulated at each engagement.The smartsite female and secondary set¿s male luer ports were measured and were within iso standards.The root cause of the customer¿s report could not be identified.

• 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: 9525771
• Report Number: 9616066-2019-03746
• Device Sequence Number: 388839
• 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,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/06/2019

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: 08/14/2022
• Device Model Number: MS3500
• Device Catalogue Number: MS3500
• Device Lot Number: 19085848
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 12/27/2019
• Supplement Report FDA Received Date: 04/16/2020; 05/07/2020
• 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: 100 ML BAXTER BAG,1000 ML BAXTER BAG, TD (B)(6) 2019; 8100, 8015
• Patient Age: 14 YR