MAUDE Adverse Event Report: CAREFUSION ALARIS NON VENTED BLOOD SET; SET, EXTENSION, INTRAVASCULAR

Model Number	2477-0000
Medical Device Problem Codes	Fluid/Blood Leak (1250); Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Information (3190)
Date of Event	02/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A 100ml baxter bag ndc 0338-0049-48 lot p375030 exp aug19 0.9% sodium chloride injection and one used hemostat.Pediatric patient.(picu).An unexpected return was received from the customer without details or information of the event.Visual inspection confirmed a leak at the bottom of the silicone pump segment (p/n 12088541).The set was received with blood throughout the tubing.Functional testing identified a leak at the same location.Closer inspection under a lab microscope observed that the leak was due to a small tear on the silicone segment.No tool marks or crush marks were observed on the lower fitment near the tear.The cause of the leak was a tear in the silicone section of the tubing.The root cause of the tear was not identified.
Event or Problem Description
The customer reported that supply chain received a set from the picu; the failure mode with the set was not provided.Although requested, no additional information was available.

• Brand Name: ALARIS NON VENTED BLOOD SET
• Common Device Name: SET, EXTENSION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8695508
• Report Number: 9616066-2019-01542
• Device Sequence Number: 11263934
• Product Code: FPA
• UDI-Device Identifier: 07613203011310
• UDI-Public: 7613203011310
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K894842
• 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): 02/04/2019

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 Model Number: 2477-0000
• Device Catalogue Number: 2477-0000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/13/2019
• 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: THERAPY DATE (B)(6) 2019