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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION ALARIS GRAVITY SET; SET, ADMINISTRATION, INTRAVASCULAR
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CAREFUSION ALARIS GRAVITY SET; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number C42013E
Medical Device Problem Codes Fluid/Blood Leak (1250); Material Separation (1562)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 03/08/2019
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, however, the customer stated that the patient was a geriatric patient.
 
Event or Problem Description
It was reported that the tubing set separated and leaked during iv sedation in the anesthesia department while in use on a geriatric patient.The customer stated that there was no patient harm caused from this event.
 
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Brand Name
ALARIS GRAVITY SET
Common Device Name
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
MDR Report Key8540454
Report Number9616066-2019-01002
Device Sequence Number2431118
Product Code FPA
UDI-Device Identifier10885403235719
UDI-Public10885403235719
Combination Product (Y/N)N
Initial Reporter StateCO
Initial Reporter CountryUS
PMA/510(K) Number
K931173
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) 03/27/2019
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 NumberC42013E
Device Catalogue NumberC42013E
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date04/23/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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