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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 20128E
Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/30/2018
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 at 2100 an infusion of tpn began then approximately 1200 the next day a leak occurred at the filter where there was a hole.There was no patient harm.
 
Manufacturer Narrative
Additional information provided.The customer¿s report of a leak at the filter was confirmed.Visual and microscopic inspection of the set observed that both filter vents looked to be wetted out (oversaturated), however there were no obvious damage to the set.Dried fluid residue was noted on the filter surface of the vent as well as the bottom vent.Functional testing confirmed leaking from bottom vent of the filter (termed ¿weeping out¿).The root cause was not identified.
 
Event Description
The customer reported that a tpn infusion was started at 2100, and by mid-afternoon the next day, a hole with leaking was identified at the filter of the extension set.There was no patient harm.
 
Manufacturer Narrative
Additional information provided.The customer¿s report of a leak at the filter was confirmed.Visual and microscopic inspection of the set observed that both filter vents looked to be wetted out (oversaturated), however there were no obvious damage to the set.Dried fluid residue was noted on the filter surface of the vent as well as the bottom vent.Functional testing confirmed leaking from bottom vent of the filter (termed ¿weeping out¿).The root cause was not identified.
 
Event Description
The customer reported that a tpn infusion was started at 2100, and by mid-afternoon the next day, a hole with leaking was identified at the filter of the extension set.There was no patient harm.
 
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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 Key7720943
MDR Text Key115075275
Report Number9616066-2018-01131
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 07/02/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/25/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number20128E
Device Catalogue Number20128E
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/06/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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