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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION ALARIS PCEA ADMINISTRATION SET MICROBORE TUBING; SET,ADMINISTRATION,INTRASVASCULAR
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CAREFUSION ALARIS PCEA ADMINISTRATION SET MICROBORE TUBING; SET,ADMINISTRATION,INTRASVASCULAR Back to Search Results
Model Number 30893-07
Medical Device Problem Code Fluid/Blood Leak (1250)
Health Effect - Clinical Code No Information (3190)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Although requested, device has not been received.A follow up report will be submitted with failure investigation results should the device be received for evaluation.
 
Event or Problem Description
It was reported leaking pcea tubing.The nurse was concerned about patient safety as the tubing for the epidural was leaking.Although requested, additional information has not been provided.This file is for encinitas.
 
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Brand Name
ALARIS PCEA ADMINISTRATION SET MICROBORE TUBING
Common Device Name
SET,ADMINISTRATION,INTRASVASCULAR
Manufacturer (Section D)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
MDR Report Key9571655
Report Number9616066-2020-00005
Device Sequence Number18947067
Product Code FPA
UDI-Device Identifier10885403460234
UDI-Public10885403460234
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
K790108
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Nurse
Type of Report Initial
Report Date (Section B) 12/13/2019
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 Date02/05/2022
Device Model Number30893-07
Device Catalogue Number30893-07
Device Lot Number19025136
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date01/09/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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