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

Model Number	10012144
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: 250ml baxter infusion bag (lot y269589 exp oct19) of norepinephrine bitartrate in 5% dextrose injection usp.The affected product has been received and the evaluation is pending.A follow up report will be submitted once the evaluation is completed.
Event or Problem Description
The customer reported that a new bag of norepinephrine was started at 0930.One hour later the bag was empty with fluid on the floor directly under the iv pole.The leak was noted at the upper blue fitment and silicone segment junction.The patient¿s vital signs were stable, and no patient harm was reported.
Additional Manufacturer Narrative
Patient was pediatric.The customer¿s report that the tubing set leaked was confirmed.Visual inspection observed that the silicone segment had a 0.0278 inch tear near the upper fitment.Visual examination under magnification noted no crush marks to the upper blue fitment.Functional and pressure testing was performed; a leak was coming out from the silicone tubing near the upper fitment.The cause of the leak was a tear in the silicone segment.The root cause of the tear was not identified.
Event or Problem Description
The customer reported that a new bag of norepinephrine was started at 0930 in the picu.One hour later the bag was empty with fluid on the floor directly under the iv pole.The leak was noted at the upper blue fitment and silicone segment junction.The patient¿s vital signs were stable, and no patient harm was reported.

• 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: 7846798
• Report Number: 9616066-2018-01482
• Device Sequence Number: 13820215
• Product Code: FPA
• UDI-Device Identifier: 07613203021159
• UDI-Public: 7613203021159
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,distri
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2018

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 Model Number: 10012144
• Device Catalogue Number: 10012144
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2018
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/05/2018
• Supplement Report FDA Received Date: 01/23/2019
• 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, THERAPY DATE: UNK.