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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 03/19/2019
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 discarded and not returned for failure investigation.The root cause of this failure was not identified.Patient age and dob were requested but not provided, however, the customer stated that the patient was an adult patient.
 
Event or Problem Description
It was reported that the tubing set separated and leaked during a normal saline and iv induction agent infusion in the anesthesia department while in use on an adult 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 Key8541146
Report Number9616066-2019-01070
Device Sequence Number400000
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 health professional
Initial Reporter Occupation Nurse
Type of Report Initial
Report Date (Section B) 04/01/2019
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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