MAUDE Adverse Event Report: CAREFUSION NON-VENTED BLOOD SET

Model Number 2477-0000

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The affected product has been received and the evaluation is pending.A follow up report will be submitted once the evaluation is completed.

Event Description

The customer reported that the tubing set leaked at the silicone pumping segment during use on a pediatric patient.There was no report of patient harm.

Manufacturer Narrative

The customer report that the tubing set leaked was confirmed.Visual inspection of the as-received set observed dried blood residue atop the blood filter drip chamber and within one of the two tubing above the blood filter drip chamber.Further inspection of both tubing engagements to their corresponding inlet ports on the top of the blood filter drip chamber identified a small amount of fluid leaking from the engagement of the tubing with the dried blood residue.Slight tugging at the engagement produced separation from the top of the drip chamber component.Additional visual inspection of the separated tubing end observed insufficient areas of expected solvent.The tubing depth was within normal limits, and dimensional analysis of the separated tubing was observed to be within specification.The root cause of the leak and separation during testing was identified as a manufacturing assembly issue of insufficient solvent applied at the engagement of the tubing to the top of the blood filter drip chamber.

Event Description

The customer reported that the tubing set leaked at the silicone pumping segment during use on a pediatric patient.There was no report of patient harm.

• Brand Name: NON-VENTED BLOOD SET
• Type of Device: BLOOD SET
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8197985
• MDR Text Key: 131488504
• Report Number: 9616066-2018-02605
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203011310
• UDI-Public: 7613203011310
• Combination Product (y/n): N
• PMA/PMN Number: K894842
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2018
• 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: 12/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1