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U.S. Department of Health and Human Services

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

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CAREFUSION SMALLBORE EXTENSION SET SET, EXTENSION, INTRAVASCULAR Back to Search Results
Model Number 20129E
Device Problem Fluid Leak (1250)
Patient Problems High Blood Pressure/ Hypertension (1908); Inadequate Pain Relief (2388)
Event Date 07/09/2018
Event Type  Injury  
Manufacturer Narrative
Although requested, the affected product has not been received. A follow up report will be submitted with investigation results should the devices be received for evaluation.
 
Event Description
The customer reported that one of the infusions of lipids, morphine, dopamine, or dobutamine was noted to be leaking from around the tubing filter and onto the floor while connected to a patient. As a result, the patient was noted to be more agitated and with a slight change in blood pressure. There was no report of lasting harm. Received a copy of the customer's sus voluntary event report from fda, which states ¿iv fluid noted on floor under lipid line. Line leaking below or around lipid filter and tpn/pt meds were backing up lipid line and dripping on floor. Infant meds included morphine gtt, dopamine, dobutamine, and precedex. Noted to be more agitated, but pressure remain stable. Stopped lipids and replaced tubing without a filter. Cleared tpn tubing to remove any excess backup of meds and started fluids. Abp slightly increased after restarting. ".
 
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Brand NameSMALLBORE 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 Key7789855
MDR Text Key117323478
Report Number9616066-2018-01319
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K960280
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 07/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/16/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/10/2021
Device Model Number20129E
Device Catalogue Number20129E
Device Lot Number18035876
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/17/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/10/2018
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: 08/16/2018 Patient Sequence Number: 1
Treatment
(3)PRI TUBING, THERAPY DATE (B)(6)
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