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

Model Number 2477-0000

Device Problems Fluid/Blood Leak (1250); Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Information (3190)

Event Date 02/01/2019

Event Type  malfunction  

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 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
• Type of Device: SET, EXTENSION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer (Section G): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer Contact: sylvia ventura ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 8695508
• MDR Text Key: 147880403
• Report Number: 9616066-2019-01542
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203011310
• UDI-Public: 7613203011310
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K894842
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: THERAPY DATE (B)(6) 2019