MAUDE Adverse Event Report: CAREFUSION SMARTSITE EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 20027E

Device Problems Patient-Device Incompatibility (2682); Fail-Safe Problem (2936)

Patient Problems Apnea (1720); Death (1802)

Event Date 08/27/2019

Event Type  Death  

Manufacturer Narrative

Concomitant medical products: 500ml eva mixing container; 10ml bd syringe, lot: 8075942, exp: 2021-03-31, 0.9% sodium chloride injection; non-bd set; 20ml bd syringe.The customer¿s report of an air leak was not confirmed.Functional testing of gravity priming, infusion testing and pressure testing did not observe any leaks or air in line throughout the received set in its as received configuration.The root cause of the customer¿s report of an air leak could not be determined.

Event Description

It was reported that on (b)(6) 2019 at around 2100, a new iv tubing was used to infuse tpn and lipids at a combined rate of 3.5ml/hr using an iv infusion pump.The infusion was administered through peripherally inserted central catheter (picc).A code blue being called (b)(6) 2019 at 0919 when the patient had an acute apneic episode.It was observed that the iv tubing with add-on filter had an air leak.Patient died on (b)(6) 2019 at 0501.An autopsy was declined and air embolism was the possible cause of death.

• Brand Name: SMARTSITE EXTENSION SET
• Type of Device: SET, ADMINISTRATION, 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: stephen bilello ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 9071090
• MDR Text Key: 158671133
• Report Number: 9616066-2019-02604
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403234859
• UDI-Public: 10885403234859
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K790108
• 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: 08/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 20027E
• Device Catalogue Number: 20027E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2019
• 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: 2420-0007,82113E,8100,8015,MZ9266, (B)(6) 2019
• Patient Outcome(s): Death
• Patient Age: 6 DA
• Patient Weight: 1