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

Model Number	2429-0500
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer complaint could not be confirmed because the device was not sequestered for failure investigation.The root cause of this failure was not identified.Although requested, patient demographics were not provided.
Event or Problem Description
It was reported that the tubing leaked below safety clamp.During a patient's infusion, it was noticed that the iv fluids were dripping on the floor from a hole in the tubing located right beneath the door of the pump.
Additional Manufacturer Narrative
The customer¿s report of tubing leaked below safety clamp could not be confirmed.The product was not returned for failure investigation and analysis.The root cause could not be identified as no product was returned.
Event or Problem Description
It was reported that the tubing leaked below the safety clamp.During a patient's infusion, it was noticed that the iv fluids were dripping on the floor from a hole in the tubing located right beneath the door of the pump.Although requested, there is no further patient or event information available.

• Brand Name: ALARIS EXTENSION SET
• Common Device Name: SET, EXTENSION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9284609
• Report Number: 9616066-2019-03082
• Device Sequence Number: 18863858
• Product Code: FPA
• UDI-Device Identifier: 10885403228018
• UDI-Public: 10885403228018
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K944320
• 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): 10/08/2019

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: 07/03/2022
• Device Model Number: 2429-0500
• Device Catalogue Number: 2429-0500
• Device Lot Number: 19075168
• 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: 11/06/2019
• Supplement Report FDA Received Date: 12/05/2019
• 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: 8100,8015,THERAPY DATE UNKNOWN