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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 8120
Device Problems Device Alarm System (1012); Failure to Analyze Signal (1539)
Patient Problem Insufficient Information (4580)
Event Date 11/14/2021
Event Type  malfunction  
Manufacturer Narrative
The event logs have been received and the evaluation is pending.A follow up report will be submitted with investigation results once the evaluation has been completed.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.H3 other text : no devices received, log review only.
 
Event Description
It was reported that the pca module showed error 351.6660.There was patient involvement but impact is unknown.
 
Manufacturer Narrative
Omit : c20 - no findings available.Additional information : imdrf annex a,b,c,g code 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.
 
Event Description
It was reported that the pca module showed error 351.6660.There was patient involvement but impact is unknown.
 
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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 Key16867041
MDR Text Key314533496
Report Number2016493-2023-157672
Device Sequence Number1
Product Code MEA
UDI-Device Identifier10885403812033
UDI-Public(01)10885403812033
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K043299
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 05/25/2023
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 Number8120
Device Catalogue Number8120 ALARIS PCA MODULE
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/12/2023
Initial Date FDA Received05/04/2023
Supplement Dates Manufacturer Received04/12/2023
Supplement Dates FDA Received06/20/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/19/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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