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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION ALARIS INFUSION HALF SET; SET, ADMINISTRATION, INTRAVASCULAR
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CAREFUSION ALARIS INFUSION HALF SET; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 28117E
Medical Device Problem Code Fluid/Blood Leak (1250)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 09/05/2018
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 not sequestered for failure investigation.The root cause of this failure was not identified.
 
Event or Problem Description
It was reported that a leak was noticed at the connection between the extension set and a port needle.The user removed the set and attached a new extension set from the same lot with no further leak issues.
 
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Brand Name
ALARIS INFUSION HALF SET
Common Device Name
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
MDR Report Key8663015
Report Number9616066-2019-01453
Device Sequence Number2130695
Product Code FPA
UDI-Device Identifier10885403274893
UDI-Public10885403274893
Combination Product (Y/N)N
Initial Reporter StateNC
Initial Reporter CountryUS
PMA/510(K) Number
K874564
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Nurse
Type of Report Initial
Report Date (Section B) 05/06/2019
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 Number28117E
Device Catalogue Number28117E
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date06/03/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
PRI TUBING,PORT NEEDLE, THERAPY DATE (B)(6) 2018
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