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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 2426-0007
Device Problems Stretched (1601); Material Deformation (2976)
Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)
Event Date 10/31/2019
Event Type  malfunction  
Manufacturer Narrative
The affected product has been received and the evaluation is pending. A follow up report will be submitted once the evaluation is completed. Although requested, additional information was not provided.
 
Event Description
Customer advocacy received a copy of the customer's medwatch report from the fda which states, "an iv infusion bolus was started in the emergency department to infused at 999ml/hr for 1 hour. After the infusion rate was decreased to 10 ml per hour. The patient was reviewed, it was noted that the tubing inside the pump had ballooned out in one spot. A new tubing was placed without concerns and worked well without difficulty. Tubing saved adn the emergency room evaluated the lot numbers. They only had one lot number so the report will list the only lot number that is currently available in the emergency department. " an incomplete date of event of (b)(6) 2019 was provided.
 
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Brand NameALARIS® PUMP MODULE ADMINISTRATION 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 Key9489615
MDR Text Key196243776
Report Number9616066-2019-03617
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 health professional,user faci
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 11/25/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/18/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2426-0007
Device Catalogue Number2426-0007
Device Lot Number19096225
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/05/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/23/2019
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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