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

Model Number	41173E
Medical Device Problem Codes	Restricted Flow rate (1248); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer complaint could not be confirmed because the product was discarded and not returned for failure investigation.The root cause of this failure was not identified.Patient age and dob requested but not provided.
Event or Problem Description
It was reported that the during an infusion of normal saline in the ed it was found that the tubing set was kinked at the y-site.The kink was significant enough that it continually occluded the flow to the patient.The customer further stated that there were no adverse effects caused to the patient from the event.
Additional Manufacturer Narrative
The customer¿s report of tubing set kinking at the y-connection could not be confirmed due to the product not returned for failure investigation.A photo of the gravity set marked by a red arrow pointing at the tubing to the smartsite inlet port indicates where the customer experienced the kink tubing, however; it does not confirm the reported kinked tubing at the y-connection on the event set.The root cause of this failure was not identified as no product was returned.
Event or Problem Description
It was reported that the during an infusion of normal saline in the ed it was found that the tubing set was kinked at the y-site.The kink was significant enough that it continually occluded the flow to the patient.The customer further stated that there were no adverse effects caused to the patient from the event.

• Brand Name: ALARIS ADMINISTRATION SET
• Common Device Name: SET,ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8927452
• Report Number: 9616066-2019-02394
• Device Sequence Number: 16210388
• Product Code: FPA
• UDI-Device Identifier: 07613203020893
• UDI-Public: 7613203020893
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K820278
• 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
• Report Date (Section B): 07/31/2019

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 Model Number: 41173E
• Device Catalogue Number: 41173E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/23/2019
• Supplement Report FDA Received Date: 10/11/2019
• 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: THERAPY DATE UNKNOWN