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

Model Number	11590100
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Separation (1562)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer¿s report that the tubing's pump segment had disconnected from the upper fitment and leaked was confirmed.Visual inspection of the set noted separation located at the engagement between the silicone pump segment tubing and the upper fitment.The ring retainer was not received with the set and a ring retainer indentation was not observed around the proximal end of the silicone pump tubing.No crush marks were observed on the upper or lower fitment.Functional testing was deemed unnecessary due to separation and obvious leaking that would occur due to the separation.The silicone pump tubing was found to be within measurement specification.Dimensional analysis was performed and the two outer diameters of the male end of the upper fitment was measured to be within specification.The root cause of the separation and leak was due to the upper fitment retainer ring on the set was not assembled onto the set during manufacturing assembly process.
Event or Problem Description
It was reported that while awaiting on peripheral iv placement on a patient, the iv tubing had been primed and placed on the iv infusion pump.The clinician found a leak, opened the door to the infusion pump and noticed that the pump segment of the tubing had separated from the upper fitment.Although requested, there was no information provided regarding patent harm.

• 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: 9092211
• Report Number: 9616066-2019-02671
• Device Sequence Number: 2298000
• Product Code: FPA
• UDI-Device Identifier: 10885403232411
• UDI-Public: 10885403232411
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K944320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/29/2019

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: 04/30/2022
• Device Model Number: 11590100
• Device Catalogue Number: 11590100
• Device Lot Number: 19047009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1