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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION ALARIS PUMP MODULE ADMINISTRATION SET; SET, ADMINISTRATION, INTRAVASCULAR
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CAREFUSION ALARIS PUMP MODULE ADMINISTRATION SET; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 2420-0500
Device Problems Fluid/Blood Leak (1250); Fracture (1260)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Although requested, product has not been received.A follow up report will be submitted with failure investigation results should the device be received for evaluation.
 
Event Description
The customer reported leaking tubing at the luer lock despite the connection being secure.The customer couldn't see a crack, but states there must have been one.
 
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Brand Name
ALARIS PUMP MODULE ADMINISTRATION SET
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
Manufacturer (Section G)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
Manufacturer Contact
ade ajibade
10020 pacific mesa blvd
san diego, CA 92121-4386
8586172000
MDR Report Key8297030
MDR Text Key134740202
Report Number9616066-2019-00204
Device Sequence Number1
Product Code FPA
UDI-Device Identifier07613203012430
UDI-Public7613203012430
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K944320
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Nurse
Type of Report Initial
Report Date 01/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/01/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number2420-0500
Device Catalogue Number2420-0500
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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