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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 2420-0007
Device Problems Obstruction of Flow (2423); No Flow (2991)
Patient Problem No Information (3190)
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.Patient's demographics requested, but was not provided.
 
Event Description
It was reported that the y tubing section of the iv tubing set was blocked where the clamp was set.Additional information was requested, but was not provided.
 
Event Description
It was reported that the y tubing was blocked where the clamp was set.There was no patient involvement.
 
Manufacturer Narrative
No product will be returned per customer.The customer complaint could not be confirmed because the product was not returned for failure investigation.The root cause of this failure was not identified.
 
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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
MDR Report Key9525744
MDR Text Key191420738
Report Number9616066-2019-03740
Device Sequence Number1
Product Code FPA
UDI-Device Identifier07613203021012
UDI-Public7613203021012
Combination Product (y/n)N
PMA/PMN Number
K944320
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 12/06/2019
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 Number2420-0007
Device Catalogue Number2420-0007
Was Device Available for Evaluation? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/27/2019
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received02/17/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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