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

Model Number	2477-0000
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product will be returned per customer.The customer complaint could not be confirmed because the product was not sequestered for failure investigation.The root cause of this failure was not identified.
Event or Problem Description
The customer reported they noticed blood leaking where the upper tubing meets the drip chamber while connected to a patient.There was no harm.
Event or Problem Description
The customer reported they noticed blood leaking where the upper tubing meets the drip chamber while connected to a patient.There was no harm.
Additional Manufacturer Narrative
Correction: date of event.
Event or Problem Description
The customer reported they noticed blood leaking where the upper tubing meets the drip chamber while connected to a patient.There was no harm.Received a copy of the customer's medwatch report which states, ¿blood tubing failures- product defect; 10 different events between (b)(6)- (b)(6) 2018.Date: (b)(6) 2018, 7ne, blood dripping from connection between chamber and tubing directly above chamber.No pt harm, psn no: (b)(4), ref ii's mw5083034, mw5083035, mw5083035, mw5083037, mw5083038.Mw5083039, mw5083040, mw5083041, and mw5083042.¿.

• Brand Name: ALARIS® PUMP MODULE ADMINISTRATION SET
• Common Device Name: SET,ADMINISTRATION,INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8215618
• Report Number: 9616066-2019-00007
• Device Sequence Number: 2027430
• Product Code: FPA
• UDI-Device Identifier: 07613203011310
• UDI-Public: 7613203011310
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K894842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/05/2018

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: 08/13/2021
• Device Model Number: 2477-0000
• Device Catalogue Number: 2477-0000
• Device Lot Number: 18085940
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 01/03/2019
• Supplement Report FDA Received Date: 01/22/2019; 02/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1