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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 Pumping Stopped (1503); Insufficient Information (3190)
Patient Problem Insufficient Information (4580)
Event Date 03/21/2023
Event Type  malfunction  
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.H3: device was not returned to manufacturing facility.
 
Event Description
It was reported that the pump shut down unexpectedly malfunctioned during insulin infusion.There was patient involvement but impact is unknown.The customer reported the issue occurred "a couple months ago" and although requested could not provide additional details.
 
Event Description
It was reported that the pump shut down unexpectedly malfunctioned during insulin infusion.There was patient involvement but impact is unknown.The customer reported the issue occurred "a couple months ago" and although requested could not provide additional details.
 
Manufacturer Narrative
Additional information: imdrf annex a and g codes.
 
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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 Key16722906
MDR Text Key313104412
Report Number2016493-2023-145305
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,Health Professional
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 04/17/2023
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 Number8100
Device Catalogue Number8100 ALARIS LVP MODULE
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/21/2023
Initial Date FDA Received04/12/2023
Supplement Dates Manufacturer Received03/21/2023
Supplement Dates FDA Received05/09/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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