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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 20029E
Device Problems Fluid/Blood Leak (1250); Hole In Material (1293)
Patient Problem No Known Impact Or Consequence To Patient (2692)
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 a tpn infusion leaked from a hole on the back side of the circular filter of the tubing.This was infusing on a single lumen picc running tpn at 20.5 ml/hr and 1l at 2.1 ml/hr.There was no report of patient harm.
 
Manufacturer Narrative
The customer¿s report of a leaking filter was confirmed.Visual inspection of the set did not reveal any discernible damage or abnormalities.Functional testing confirmed a slow leak began to appear from the filter vent.The cause of the formation of a leak has been determined to be the clogging of the filter with infusate due to the nature of the infusate and/or duration of exposure, at which time the infusate will seek the path of least resistance and begin to leak from the air vent.
 
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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
MDR Report Key7255117
MDR Text Key99912882
Report Number9616066-2018-00158
Device Sequence Number1
Product Code FPB
Combination Product (y/n)N
PMA/PMN Number
K801614
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 01/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/08/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number20029E
Device Catalogue Number20029E
Other Device ID Number10885403234866
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/09/2018
Date Manufacturer Received04/05/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
PICC LINE, THERAPY DATE UNK
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