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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 C25013E
Medical Device Problem Codes Break (1069); Fluid/Blood Leak (1250)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 02/26/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Post market surveillance for med consumables.Although requested, product has not been received.A follow up report will be submitted with failure investigation results should the product be received for evaluation.Although requested, patient demographics not provided.
 
Event or Problem Description
The customer reported that during contrast injection using a nonbd ct insection system, the tubing broke and contrast leaked out.There was no harm.
 
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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 Key8412220
Report Number9616066-2019-00724
Device Sequence Number1975783
Product Code FPA
UDI-Device Identifier10885403235627
UDI-Public10885403235627
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
K960280
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,distri
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 02/27/2019
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 Expiration Date09/22/2021
Device Model NumberC25013E
Device Catalogue NumberC25013E
Device Lot Number18096715
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date03/12/2019
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
NONBD CT INSECTION SYSTEM, THERAPY DATE (B)(6) 2019
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