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

Model Number 20029E

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

Patient Problem No Information (3190)

Event Date 03/09/2016

Event Type  Injury  

Manufacturer Narrative

No product will be returned per customer.The customer¿s complaint could not be confirmed because the product was not sequestered and will not be returned for failure investigation.The root cause of this failure was not identified.

Event Description

The customer reported that a nurse noticed the port cracked at the connection to the primary tubing.The nurse stated that tpn had spilled into the patient¿s bed and blood was noted to be backing up to the tubing filter.Additional lab work was ordered by md.The patient¿s blood sugar was low however unspecified.The customer reported ¿minimal patient harm.¿.

• 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: 5575214
• MDR Text Key: 42604108
• Report Number: 9616066-2016-00514
• 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
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 03/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2018
• Device Model Number: 20029E
• Device Catalogue Number: 20029E
• Device Lot Number: 15116613
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/14/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/19/2015
• 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
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 238 DA