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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 20129E
Device Problems Failure to Infuse (2340); Obstruction of Flow (2423); Insufficient Information (3190)
Patient Problem No Information (3190)
Event Date 07/06/2019
Event Type  malfunction  
Manufacturer Narrative
Although requested, the affected product has not been received. A follow up report will be submitted with investigation results should the devices be received for evaluation. The event reportedly occurred in the nicu; therefore it is presumed the patient was a neonate.
 
Event Description
It was reported that the lipid tubing and the 1. 2 micron filter extension set was changed the previous evening per protocol. At mid- morning the device alarmed for occlusion alarms. The rn stated that there was no lipids could be seen in the picc lumen, the user disconnected the line and attempted to flush however the line was occluded, the line was then removed and the infusion started without difficulty.
 
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Brand NameALARIS® EXTENSION 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
stephen bilello
10020 pacific mesa blvd
san diego, CA 92121-4386
8586172000
MDR Report Key8851960
MDR Text Key153272361
Report Number9616066-2019-02149
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K960280
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 07/09/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/01/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number20129E
Device Catalogue Number20129E
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
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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