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

Model Number 20127E

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/14/2016

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 leaking at the filter during an infusion of lipids at 1ml per hr.The iv was attached to a umbilical vessel catheter.Upon closer observation it was noted that the filter and iv tubing were cracked.The iv set and filter were replaced and continued the infusion of lipids without a filter.No patient harm reported.

Manufacturer Narrative

Concomitant medical products: 250 ml baxter intralipid 20% fat emulsion iv bag, with lot number 10ih4242 and an expiration of 07/2017; therapy date (b)(6) 2016.The customer¿s report of a leak at the filter was confirmed.The report of a crack was not confirmed.Visual inspection showed no cracks.Functional testing found that the leak originated from the filter vent.The probable cause of the filter vent leak was an oversaturated filter.

• Brand Name: SMARTSITE 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: 5644339
• MDR Text Key: 44854991
• Report Number: 9616066-2016-00628
• 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: health professional,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/22/2016

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: 20127E
• Device Catalogue Number: 20127E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/22/2016
• Initial Date FDA Received: 05/10/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/12/2016
• 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