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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION CORPORATION ALARIS PUMP MODULE ADMINISTRATION SET
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CAREFUSION CORPORATION ALARIS PUMP MODULE ADMINISTRATION SET Back to Search Results
Model Number 2420-0500
Device Problems Leak/Splash (1354); Split (2537); Chemical Spillage (2894)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Event Description
Customer reported the set has split and was leaking at the distal end at the connector between the rotating luer lock collar and the piece above it.Chemotherapy drug leaked, causing an exposure and the need to replace the therapy, causing a delay in treatment.The event occurred in the inpatient oncology department.No details of the exposure were provided but no patient or staff harm was reported.
 
Manufacturer Narrative
(b)(4).This report was filed by the manufacturer.The affected product has been received and the investigation is pending.A follow up report will be submitted once the failure investigation has been completed.
 
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Brand Name
ALARIS PUMP MODULE ADMINISTRATION SET
Manufacturer (Section D)
CAREFUSION CORPORATION
san diego CA
Manufacturer Contact
stephen bilello
10020 pacific mesa blvd.
san diego, CA 92121
8586176477
MDR Report Key3855938
MDR Text Key22003065
Report Number9616066-2014-00294
Device Sequence Number1
Product Code FPA
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 Other,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 01/30/2014
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
Device Operator Health Professional
Device Model Number2420-0500
Device Catalogue Number2420-0500
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer03/19/2014
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 03/10/2014
Initial Date FDA Received03/27/2014
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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