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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 2426-0007
Device Problems Fluid Leak (1250); Cut In Material (2454)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
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 Description
The customer reported the nurse attached the set to the patient, and the iv fluids leaked because there is a slit below the one of the fitments. There was no patient harm.
 
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Brand NameALARIS® PUMP MODULE ADMINISTRATION SET
Type of DeviceSET, 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
mustafa omar
10020 pacific mesa blvd
san diego, CA 92121-4386
8586172000
MDR Report Key7567734
MDR Text Key110036000
Report Number9616066-2018-00733
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/14/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/04/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2426-0007
Device Catalogue Number2426-0007
Other Device ID Number10885403227998
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/07/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/07/2018
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

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