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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION MAXGUARD EXTENSION SET; SET, EXTENSION, INTRAVASCULAR
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CAREFUSION MAXGUARD EXTENSION SET; SET, EXTENSION, INTRAVASCULAR Back to Search Results
Model Number ME5303
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Information (3190)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
No product will be returned per customer.The customer complaint could not be confirmed because the product was not sequestered for failure investigation.The root cause of this failure was not identified.Although requested, patient demographics not provided.
 
Event or Problem Description
The customer reported that the slide clamp on the extension set breaks.The broken clamp does not prevent flow, therefore, the nurses continue to infuse with the set.Although requested there was no other information provided.
 
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Brand Name
MAXGUARD EXTENSION SET
Common Device Name
SET, EXTENSION, INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
MDR Report Key8394883
Report Number9616066-2019-00620
Device Sequence Number1628168
Product Code FPA
UDI-Device Identifier10885403274435
UDI-Public10885403274435
Combination Product (Y/N)N
Initial Reporter StateMI
Initial Reporter CountryUS
PMA/510(K) Number
K083472
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date (Section B) 02/11/2019
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 Model NumberME5303
Device Catalogue NumberME5303
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date03/06/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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