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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION MICROBORE EXTENSION SET SET, EXTENSION, INTRAVASCULAR

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CAREFUSION MICROBORE EXTENSION SET SET, EXTENSION, INTRAVASCULAR Back to Search Results
Model Number 30914
Device Problem Fluid Leak (1250)
Patient Problems Apnea (1720); Bradycardia (1751); Underdose (2542)
Event Date 12/20/2018
Event Type  Injury  
Manufacturer Narrative
Concomitant medical product: microclave, therapy date: (b)(6) 2018. Apnea and bradycardia episodes due to prematurity. Premature infant; patient was a twin that was born at 28 week 5 days; this is the corrected gestational age in medwatch additional information. Patient was 6 days old documented on mw however customer corrected gestational age to 28 week 5 days. Patient on ram cpap for ventilation and oxygenation. Not hispanic/latino. Race- black or african american. Weight (b)(6) documented on medwatch without the units, the customer confirmed the patient weight is in grams. (b)(6) -documented as (b)(6). Apnea and bradycardia episodes due to prematurity. The affected product has been received and the investigation is pending. A follow up report will be submitted once the failure investigation has been completed.
 
Event Description
Received a copy of the customer's medwatch report from the fda which states, "preterm infant was receiving cafcit (caffeine citrate} iv every 12 hours for apnea and bradycardia episodes due to prematurity. Rn gave dose on at 2118 and noted that patient was having increased episodes of apnea and bradycardia in which the infant required mild stimulation to recover. Rn then noticed that the iv tubing was wet on the exterior and changed the iv tubing. She then attempted to flush the line and noted that there was leaking at the hub of the tubing. Infant most likely did not receive entire dose of cafcit at 2118. " an incomplete date of event of (b)(6) 2018 was provided. Intended procedure: infusion of central nervous system stimulant to preterm infant to prevent apnea and bradycardia episodes. The event occurred in the nicu. The customer later reported that a gentle touch of the infant assisted the patient to recover from the apnea and bradycardia. The patient was currently still in the nicu due to the extreme premature birth as of (b)(6) 2019. It was reported that the set was in use for less than 24 hrs. The cafcit (caffeine citrate) infusion was initiated on (b)(6) at 2225pm.
 
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Brand NameMICROBORE EXTENSION SET
Type of DeviceSET, EXTENSION, 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
ade ajibade
10020 pacific mesa blvd
san diego, CA 92121-4386
8586172000
MDR Report Key8321326
MDR Text Key135569516
Report Number9616066-2019-00301
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 health professional,user faci
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/08/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/03/2021
Device Model Number30914
Device Catalogue Number30914
Device Lot Number18025196
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/07/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/03/2018
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: 02/08/2019 Patient Sequence Number: 1
Treatment
8015,8110,SYR TUBE,IV FLUSH,SYRINGE, TD: (B)(6) 2018
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