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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION ALARIS EXTENSION SET; SET, EXTENSION, INTRAVASCULAR
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CAREFUSION ALARIS EXTENSION SET; SET, EXTENSION, INTRAVASCULAR Back to Search Results
Model Number 20027E
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/27/2016
Event Type  malfunction  
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 upon attaching a primed tpn infusion to a double lumen hickman catheter, the nurse noted leaking at the connection of the primary line with the 0.2 micron filter.The nurse then clamped the line, briefly detached the filter and reattached it to the end of the tubing below the infusion pump.When the infusion was restarted, the dripping occurred in the same location as previously noted.The 0.2 micron filter (only) was removed and replaced with a new filter, and the infusion continued without further leaks.
 
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Brand Name
ALARIS EXTENSION SET
Type of Device
SET, 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 Key5462033
MDR Text Key39083889
Report Number9616066-2016-00333
Device Sequence Number1
Product Code FPB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K801614
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 02/01/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/25/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number20027E
Device Catalogue Number20027E
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received04/22/2016
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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