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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION ALARIS EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR
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CAREFUSION ALARIS EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 20059E
Device Problem Pressure Problem (3012)
Patient Problem No Known Impact Or Consequence To Patient (2692)
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
It was reported that during computed tomography (ct) scans there were issues with the contrast injectors spiking pressure.
 
Event Description
It was reported that during a computed tomography (ct) scan a extension set was involved with the contrast injectors spiking pressure.
 
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 EXTENSION SET
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
MDR Report Key9344272
MDR Text Key188696273
Report Number9616066-2019-03364
Device Sequence Number1
Product Code FPA
UDI-Device Identifier07613203012317
UDI-Public7613203012317
Combination Product (y/n)N
PMA/PMN Number
K960280
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Type of Report Initial,Followup
Report Date 11/04/2019
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 Number20059E
Device Catalogue Number20059E
Was Device Available for Evaluation? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/19/2019
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received02/12/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
BD INSYTE AUTOGUARD , THERAPY DATE: UNK
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