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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 Known Impact Or Consequence To Patient (2692)
Date of Event 08/06/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
No product will be returned per customer.The customer complaint of blood tubing set leak was confirmed per picture provided observed that blood was leaking from the pvc tubing to the drip chamber blood filter top cap inlet port.The root cause of this failure was not identified.
 
Event or Problem Description
The customer reported that the rn initiated a blood transfusion at 4:35 p.M.And noted that the tubing set began to leak at the top engagement of the in-line filter.There was no patient harm.
 
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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 Key7840154
Report Number9616066-2018-01458
Device Sequence Number11374381
Product Code FPA
UDI-Device Identifier10885403235122
UDI-Public10885403235122
Combination Product (Y/N)N
Initial Reporter StateOH
Initial Reporter CountryUS
PMA/510(K) Number
K894842
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Nurse
Type of Report Initial
Report Date (Section B) 08/08/2018
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 Number2478-0000
Device Catalogue Number2478-0000
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date08/31/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Patient Age56 YR
Patient Weight85
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