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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION ALARIS EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR
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CAREFUSION ALARIS EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 11275183
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 09/04/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
No product will be returned per customer.The customer¿s complaint could not be confirmed because the product was not sequestered and will not be returned for failure investigation.The root cause of this failure was not identified.
 
Event or Problem Description
The customer reported the tubing was leaking at the connection site where the texium cap and tubing connect.The leaked appeared to be a crack at the tubing connection that did not involve the texium cap itself.There was no patient harm.
 
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Brand Name
ALARIS EXTENSION SET
Common Device Name
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
MDR Report Key7985487
Report Number9616066-2018-01898
Device Sequence Number13766850
Product Code FPA
UDI-Device Identifier10885403234712
UDI-Public10885403234712
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) 09/04/2018
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 Number11275183
Device Catalogue Number11275183
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date10/19/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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