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U.S. Department of Health and Human Services

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

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CAREFUSION SMARTSITE EXTENSION SET SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
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.
 
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Brand NameSMARTSITE EXTENSION SET
Type of DeviceSET, 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 Key9071090
MDR Text Key158671133
Report Number9616066-2019-02604
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K790108
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
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 Received09/16/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number20027E
Device Catalogue Number20027E
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/05/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
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 Treatment Data
Date Received: 09/16/2019 Patient Sequence Number: 1
Treatment
2420-0007,82113E,8100,8015,MZ9266, (B)(6) 2019
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