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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION NON-VENTED BLOOD SET
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CAREFUSION NON-VENTED BLOOD SET Back to Search Results
Model Number 2478-0000
Medical Device Problem Code Fluid/Blood Leak (1250)
Health Effect - Clinical Code No Information (3190)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Although requested, product has not been received.A follow up report will be submitted with failure investigation results should the device be received for evaluation.
 
Event or Problem Description
It was reported that there was a blood tubing leak.Fifteen minutes after the blood transfusion was started, a leak occurred above the drip chamber at the connection of the tubing resulting in blood dripping down onto the iv pump and floor.The transfusion was continued with a new blood set.
 
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Brand Name
NON-VENTED BLOOD SET
Common Device Name
BLOOD SET
Manufacturer (Section D)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
MDR Report Key8582652
Report Number9616066-2019-01213
Device Sequence Number13890326
Product Code FPA
UDI-Device Identifier10885403235122
UDI-Public10885403235122
Combination Product (Y/N)N
Initial Reporter StateWI
Initial Reporter CountryUS
PMA/510(K) Number
K894842
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,other
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 04/09/2019
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 Date11/24/2021
Device Model Number2478-0000
Device Catalogue Number2478-0000
Device Lot Number18116220
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date05/06/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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