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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 10373772
Medical Device Problem Codes Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code No Information (3190)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
No product will be returned per customer.The customer complaint could not be confirmed because the product was discarded and not returned for failure investigation.The root cause of this failure was not identified.Although requested, patient demographics not provided.
 
Event or Problem Description
It was reported that the extension tubing set "hub" cracked and leaked d10w after four hours after the intravenous was placed.The nurse does not know whether the tubing set was already cracked or whether the crack occurred when it was positioned.The event occurred in the neonatal intensive care unit.Although requested, no additional information was provided.
 
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Brand Name
ALARIS® EXTENSION SET
Common Device Name
SET, EXTENSION, INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
MDR Report Key9948123
Report Number9616066-2020-01296
Device Sequence Number17003011
Product Code FPA
UDI-Device Identifier10885403234194
UDI-Public10885403234194
Combination Product (Y/N)N
Initial Reporter StateNC
Initial Reporter CountryUS
PMA/510(K) Number
K790108
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional,other
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 03/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model Number10373772
Device Catalogue Number10373772
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date04/10/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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