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	11/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although requested, device has not been received.A follow up report will be submitted with failure investigation results should the device be received for evaluation.
Event or Problem Description
The customer reported that blood was leaking from the non-used y spike from above the chamber while connected to a patient.There was no harm.
Additional Manufacturer Narrative
Addition: g.3.Correction: e.4.
Event or Problem Description
The customer reported that the tubing separated at the1st y-site after the drip chamber and pulled blood from port onto the floor.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)- (8)(6) 2018.Date: {b){6) 2018; location: 7se, tubing broke i separated at 1st y­ site after chamber; tubing pulled blood from port onto ground.No pt harm, psn no: {8)(4).Ref#'s mw5083034, mw5083035.Mw5083036, mw5083037, mw5083038, mw5083039.Mw5083040, mw5083041, and mw5083042.".
Additional Manufacturer Narrative
The customer¿s report of sets leaking from spike was confirmed.The suspect set was not returned for investigation; three new unused sets model 2477-0000, lot 18086026 were returned.During visual inspection, it was noted immediately that the pvc tubing was completely separated from one of the two drip chamber blood filter inlet ports on two of the three sets received.Functional testing was performed and the tubing set separated from the pvc tubing to the filter inlet port causing fluid to leak from the separation.The tubing was within specification on all three returned sets.Visual inspection under microscope noted that both sides of the pvc tubing had insufficient solvent applied at the engagement during manufacturing process on all three samples received.The cause of the leak was due to tubing separation.The root cause of the separation was identified as a manufacturing issue due to insufficient solvent being applied at the junction of the pvc tubing on all three unused sets received.
Event or Problem Description
The customer reported that blood was leaking from the non-used y spike from above the 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)- (8)(6) 2018.Date: (8)(6) 2018, 7ne.Blood seeping from non-used y spike on tubing above chamber lot: (10)18086026, no pt harm, (8)(4).Ref#'s mw5083033, mw5083035, mw5083036, 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: 8215665
• Report Number: 9616066-2019-00009
• Device Sequence Number: 16606982
• 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): 11/16/2018

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: 08/14/2021
• Device Model Number: 2477-0000
• Device Catalogue Number: 2477-0000
• Device Lot Number: 18086026
• 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: 02/07/2019; 05/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1