MAUDE Adverse Event Report: CAREFUSION ALARIS 16 IN NON-DEHP EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	MX9166
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer¿s report that the tubing leaked was not confirmed.The customer¿s experience was not replicated because the sets primed and infused completely during functional testing.The sets were visually inspected for obvious damage such as cracks, kinks, holes, and tears in the tubing and their components.No anomalies or evidence of damage were observed on the filters or the sets upon visual inspection.Functional testing did not replicate any leaks within the extension sets¿ filters or throughout the sets.Pressure testing also found no leaking or other anomalies with the returned sets.It is suggested that the customer review the guide for ¿iv in line filters¿.
Event or Problem Description
It was reported that the tubing leaked.There was no patient harm reported.

• Brand Name: ALARIS 16 IN NON-DEHP EXTENSION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9193540
• Report Number: 9616066-2019-02899
• Device Sequence Number: 19773868
• Product Code: FPA
• UDI-Device Identifier: 10885403237652
• UDI-Public: 10885403237652
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Report Date (Section B): 09/20/2019

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: 01/30/2024
• Device Model Number: MX9166
• Device Catalogue Number: MX9166
• Device Lot Number: 19017181
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1