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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION ALARIS® SE PUMP ADMINISTRATION SET; SET, ADMINISTRATION, INTRAVASCULAR
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CAREFUSION ALARIS® SE PUMP ADMINISTRATION SET; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 11499817-09
Device Problem Fracture (1260)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/15/2017
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 logs/device be received for evaluation.
 
Event Description
The report suggests that when the user tried to connect the blood set to the patient cannula the luer lock connector cracked.
 
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Brand Name
ALARIS® SE PUMP 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
stephen bilello
10020 pacific mesa blvd
san diego, CA 92121-4386
8586172000
MDR Report Key6609072
MDR Text Key76556600
Report Number9616066-2017-00838
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeGB
PMA/PMN Number
K931550
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Other
Type of Report Initial
Report Date 05/17/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/02/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/01/2019
Device Model Number11499817-09
Device Catalogue Number11499817-09
Device Lot Number16056451
Other Device ID Number11499817
Was Device Available for Evaluation? No
Date Manufacturer Received05/17/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/16/2016
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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