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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION MAXZERO EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR
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CAREFUSION MAXZERO EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number MZ9271
Medical Device Problem Code Fluid/Blood Leak (1250)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 04/08/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The customer¿s report of the set leaking near the filter was confirmed.Visual inspection showed no obvious damage or issues.Pressure testing resulted in a leak at the engagement between the filter outlet and tubing.Inspection under magnification showed insufficient/lack of solvent at the tubing engagement.The root cause of the insufficient solvent is improper assembly due to equipment and/or operator error.
 
Event or Problem Description
The set was received as an unexpected product returned.A note attached to the returned product states "leaking near filter." blood was seen in the fluid path.There was no report of patient harm.
 
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Brand Name
MAXZERO EXTENSION SET
Common Device Name
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
MDR Report Key7696574
Report Number9616066-2018-01041
Device Sequence Number13678809
Product Code FPA
UDI-Device Identifier10885403240744
UDI-Public10885403240744
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
K140831
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,other
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 06/22/2018
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 NumberMZ9271
Device Catalogue NumberMZ9271
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/25/2018
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date07/17/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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