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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION MAXGUARD EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR
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CAREFUSION MAXGUARD EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number ME1224
Medical Device Problem Code Fluid/Blood Leak (1250)
Health Effect - Clinical Code No Information (3190)
Date of Event 07/03/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Unable to determine the cause of the customer's reported complaint because the set has been discarded by the customer and will not be returned.The root cause of this failure could not be identified.Patient age and dob requested but not provided.
 
Event or Problem Description
It was reported that the patient was in diabetic ketoacidosis (dka) receiving a dka protocol infusion of dka fluids and insulin when the trifuse tubing set leaked at the junction of the 3 arms.
 
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Brand Name
MAXGUARD EXTENSION SET
Common Device Name
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
MDR Report Key8851963
Report Number9616066-2019-02163
Device Sequence Number259878
Product Code FPA
UDI-Device Identifier10885403236112
UDI-Public10885403236112
Combination Product (Y/N)N
Initial Reporter StateOK
Initial Reporter CountryUS
PMA/510(K) Number
K051499
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 07/10/2019
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 Date11/02/2022
Device Model NumberME1224
Device Catalogue NumberME1224
Device Lot Number17115444
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date08/01/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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