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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION ALARIS EXTENSION SET; SET, EXTENSION, INTRAVASCULAR
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CAREFUSION ALARIS EXTENSION SET; SET, EXTENSION, INTRAVASCULAR Back to Search Results
Model Number 20043E
Medical Device Problem Code Crack (1135)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 02/19/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
No product will be returned per customer.No investigation was performed.
 
Event or Problem Description
It was reported that the t-connector cracked on the neonatal intensive [nicu] care unit.The crack occurred during a picc line t-connector change out - the t-connector cracked during sterile cap change.The alaris lvp was infusing d12.5 1/2ns +10meq/l kcl+ 0.5unit/ml heparin.No hemostats were used during the change out.This did not impact the patient.
 
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Brand Name
ALARIS EXTENSION SET
Common Device Name
SET, EXTENSION, INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
MDR Report Key9806865
Report Number9616066-2020-00744
Device Sequence Number16304489
Product Code FPA
UDI-Device Identifier10885403234873
UDI-Public10885403234873
Combination Product (Y/N)N
Initial Reporter StateTN
Initial Reporter CountryUS
PMA/510(K) Number
K960280
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) 02/14/2020
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 Number20043E
Device Catalogue Number20043E
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date03/09/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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