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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION SD ALARIS SYSTEM; PUMP, INFUSION
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CAREFUSION SD ALARIS SYSTEM; PUMP, INFUSION Back to Search Results
Model Number 8100
Device Problems Break (1069); Contamination (1120); Insufficient Flow or Under Infusion (2182)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/18/2024
Event Type  malfunction  
Event Description
It was reported that there was an under infusion of an unspecified medication where the pump indicated 399ml was infused while the expected drug volume was 346ml.There was patient involvement but no harm.
 
Manufacturer Narrative
A follow up report will be submitted with investigation results should the device be repaired or the device/logs be received for evaluation.Per 803.52(f)(11)(iii) the information provided represents all of the known information at this time.The complainant or reporter was unable or unwilling to provide any further patient, product, or procedural details to the manufacturer.
 
Event Description
It was reported that there was an under infusion of an unspecified medication where the pump indicated 399ml was infused while the expected drug volume was 346ml.There was patient involvement but no harm.
 
Manufacturer Narrative
Omit: b17 - device not returned, c20 - no findings available additional information : device available for eval?, returned to manufacturer on, device return to manuf.?, device eval by manufacturer? , if other specify, imdrf annex a,g,b,c and d codes and manufacturer narrative a device history record review is performed on each device reported in a mdr reportable event along with other methods of investigation as coded in section h6 of this mdr report.H3 other text : not applicable.Device evaluated by bd.
 
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Brand Name
ALARIS SYSTEM
Type of Device
PUMP, INFUSION
Manufacturer (Section D)
CAREFUSION SD
10020 pacific mesa blvd
san diego CA 92121 4386
Manufacturer (Section G)
CAREFUSION SD
10020 pacific mesa blvd
san diego CA 92121 4386
Manufacturer Contact
brett wilko
10020 pacific mesa blvd
san diego, CA 92121-4386
8586172000
MDR Report Key18719409
MDR Text Key335560332
Report Number2016493-2024-14815
Device Sequence Number1
Product Code FRN
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K133532
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation 505
Type of Report Initial,Followup
Report Date 04/02/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/16/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number8100
Device Catalogue Number8100 ALARIS LVP MODULE
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Manufacturer Received01/25/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/07/2008
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
8015
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