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

Model Number	11607704
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product 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
It was reported that after spiking the propofol bottle and inserting the tubing set into the pump, it was noted that the tubing set was leaking.Upon observation, it was noted that the leak was found to be at the upper fitment.The customer later stated that there was no patient involvement.
Additional Manufacturer Narrative
The customer¿s report of tubing set leaked at upper fitment was confirmed.The set was visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.No anomalies were observed on the set during visual inspection.Functional testing observed a leak from the tubing engagement to the upper fitment component.Further inspection of the observed leaking engagement observed the tubing sides not fully adhered along the inner wall of the upper fitment.The tubing was also attempted to be slightly tugged in which no separation was observed.The root cause was due to a manufacturing assembly issue.
Event or Problem Description
It was reported that after spiking the propofol bottle and inserting the tubing set into the pump, it was noted that the tubing set was leaking.Upon closer observation, it was noted that the leak was found to be at the upper fitment.The customer later stated that there was no patient involvement.Customer advocacy received a copy of the customer's medsun report from the fda which states, "alaris iv pump tubing set was used to spike a new bottle of propofol upon inserting the tubing into the iv pump, it became apparent the tubing was leaking upon further investigation it was noted that the medication was leaking from just above the blue connector hub from the "hard tubing" into the "soft" tubing that runs through the pump." the medsun states that the event occurred in the critical care department.
Additional Manufacturer Narrative
Additional patient information: ethnicity: not hispanic/latino.
Event or Problem Description
It was reported that after spiking the propofol bottle and inserting the tubing set into the pump, it was noted that the tubing set was leaking.Upon observation, it was noted that the leak was found to be at the upper fitment.The customer later stated that there was no patient involvement.Customer advocacy received a copy of the customer's medsun report from the fda which states, "alaris iv pump tubing set was used to spike a new bottle of propofol upon inserting the tubing into the iv pump, it became apparent the tubing was leaking upon further investigation it was noted that the medication was leaking from just above the blue connector hub from the "hard tubing" into the "soft" tubing that runs through the pump." the medsun states that the event occurred in the critical care department.

• 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: 8913678
• Report Number: 9616066-2019-02293
• Device Sequence Number: 1746486
• Product Code: FPA
• UDI-Device Identifier: 10885403228001
• UDI-Public: 10885403228001
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K944320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/24/2019

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: 04/04/2022
• Device Model Number: 11607704
• Device Catalogue Number: 11607704
• Device Lot Number: 19045519
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 08/20/2019
• Supplement Report FDA Received Date: 10/28/2019; 12/09/2019
• 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, TD (B)(6) 2019.