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	11/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received and the evaluation is pending.A follow up report will be submitted with investigation results once the evaluation has been completed.
Event or Problem Description
The customer reported they primed the tubing then 10 seconds later they noticed a leak where the spiked tubing meets the drip chamber while connected to a patient.There was no harm.
Event or Problem Description
The customer reported they primed the tubing then 10 seconds later they noticed a leak where the spiked 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; location: 8ne.Primed tubing;10 seconds later was leaking atop where tubing meets chamber.No pt harm, psn no: (b)(4), ref #'s mw5083033, mw5083034.Mw5083035, mw5083036.Mw5083037.Mw5083038, mw5083039, mw5083041, and mw5083042.¿.
Additional Manufacturer Narrative
The customer report of a leak where the spiked tubing meets the drip chamber was confirmed.Visual inspection of the set showed dried blood residue atop the blood filter drip chamber.During functional testing fluid was observed to leak out at the engagement from one of the pvc tubings to the blood filter drip chamber.The root cause was identified as an assembly issue of insufficient solvent being applied at the engagement of the tubing.
Event or Problem Description
The customer reported they primed the tubing then 10 seconds later they noticed a leak where the spiked 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 (6)(6)- (8)(6) 2018.Date: (6){6) 2018; location: 8ne.Primed tubing;10 seconds later was leaking atop where tubing meets chamber.No pt harm, psn no: (6)(4), ref ii's (b)(4).¿.

• 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: 8215198
• Report Number: 9616066-2019-00003
• Device Sequence Number: 1987315
• 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): 12/06/2018

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2018
• 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: 02/08/2019; 03/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1