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

Model Number	2120-0500
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although requested, product 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
It was reported that the user was priming the tubing with saline when the nurse noticed that the tubing broke at the distal end of the set.The customer confirmed that there was no patient involvement.
Additional Manufacturer Narrative
Additional medwatch information provided.
Event or Problem Description
Customer advocacy received a copy of the customer's medwatch report from the fda which states, "alaris pump iv tubing was removed from the package, nurse went to prime tubing to find that it was broken it was broken towards the end of the line, not near any of the blue areas no one was exposed, the nurse noticed it when priming the tubing with normal saline.".
Additional Manufacturer Narrative
The customer¿s report that the tubing broke (determined to be incorrect component installed) at the distal end of the set was confirmed.The set was visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.Visual inspection of the set noted the set¿s male luer was missing the y-site was also assembled inverted on the distal end of the set.No other abnormalities were observed.Functional testing was deemed unnecessary due to the misassembled set.The root cause of the misassembled set was due to operator error of not following manufacturing process sequence during the set¿s assembly.
Event or Problem Description
It was reported that the user was priming the tubing with saline when the nurse noticed that the tubing broke at the distal end of the set.The customer confirmed that there was no patient involvement.Customer advocacy received a copy of the customer's medwatch report from the fda which states, "alaris pump iv tubing was removed from the package, nurse went to prime tubing to find that it was broken it was broken towards the end of the line, not near any of the blue areas no one was exposed, the nurse noticed it when priming the tubing with normal saline".

• 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: 9324415
• Report Number: 9616066-2019-03250
• Device Sequence Number: 16247974
• Product Code: FPA
• UDI-Device Identifier: 07613203012690
• UDI-Public: 7613203012690
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 10/22/2019

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: 08/14/2022
• Device Model Number: 2120-0500
• Device Catalogue Number: 2120-0500
• Device Lot Number: 19086005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 11/14/2019
• Supplement Report FDA Received Date: 12/09/2019; 02/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1