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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION EXTENSION SET; SET,EXTENSION,INTRAVASCULAR
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CAREFUSION EXTENSION SET; SET,EXTENSION,INTRAVASCULAR Back to Search Results
Model Number MX9166
Medical Device Problem Code Fluid/Blood Leak (1250)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 07/10/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Although requested, device has not been received.A follow up report will be submitted with failure investigation results should the device be received for evaluation.No harm to patient.
 
Event or Problem Description
It was reported that the tubing set filter leaked from the "circle area" on the backside of the filter.It was stated; that this "happened almost daily" while the patient was in the picu as well.There was not patient harm.
 
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Brand Name
EXTENSION SET
Common Device Name
SET,EXTENSION,INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
MDR Report Key9194861
Report Number9616066-2019-02844
Device Sequence Number3671718
Product Code FPA
UDI-Device Identifier10885403237652
UDI-Public10885403237652
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
K051499
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) 09/17/2019
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 Date01/30/2024
Device Model NumberMX9166
Device Catalogue NumberMX9166
Device Lot Number19017181
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date10/15/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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