MAUDE Adverse Event Report: CAREFUSION ALARIS EXTENSION SET; FILTER, INFUSION LINE

Model Number 20029E

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 a leaking filter extension set while on a patient.No patient harm reported.

Manufacturer Narrative

The customer¿s report of a leak was not confirmed.Visual inspection observed no obvious damages or any issues.Functional testing was performed.The set was attempted to be reprimed via a lab syringe filled with blue dyed fluid.No leaks or any issues were observed anywhere on the set.A lab extension set was also attached to the set's luer end and was pressure tested up to 30psi while submerged underwater in which no leaks or any issues were also observed.The root cause of the reported leak was not identified.

• Brand Name: ALARIS EXTENSION SET
• Type of Device: FILTER, INFUSION LINE
• 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: stephen bilello ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 5416076
• MDR Text Key: 37720311
• Report Number: 9616066-2016-00232
• Device Sequence Number: 1
• Product Code: FPB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K801614
• 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,Followup,Followup
• Report Date: 01/21/2016

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
• Device Operator: Health Professional
• Device Model Number: 20029E
• Device Catalogue Number: 20029E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/26/2016
• Initial Date FDA Received: 02/08/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 05/20/2016; 06/15/2016
• 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