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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 Backflow (1064); Partial Blockage (1065); Fluid Leak (1250); Material Puncture/Hole (1504)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/13/2019
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 product be received for evaluation.
 
Event Description
It was reported from the surgical unit that there was a hole in the iv tubing set which resulted in fluids on the ground. Blood backflow was visible in the tubing and caused significant clotting in the midline and buff cap. There was no impact to the patient.
 
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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
sylvia ventura
10020 pacific mesa blvd
san diego, CA 92121-4386
8586172000
MDR Report Key9572300
MDR Text Key184673795
Report Number9616066-2020-00043
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
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 12/16/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/09/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2426-0007
Device Catalogue Number2426-0007
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/15/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? Yes
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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