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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION SD ALARIS SYSTEM; INFUSION PUMP
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CAREFUSION SD ALARIS SYSTEM; INFUSION PUMP Back to Search Results
Model Number 8120
Device Problems Contamination (1120); Corroded (1131); Excess Flow or Over-Infusion (1311); Device Markings/Labelling Problem (2911); Mechanics Altered (2984)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/07/2021
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.No devices received, log review only.
 
Event Description
It was reported from the pediatric unit that a fentanyl pca was set-up for one initial bolus and subsequent patient-initiated dosing only.The patient received an initial bolus of 7.5 ml of fentanyl (75 mcg of a 10 mcg/ml 50 ml syringe).After 2 hours it appeared that the entire 500mcg of fentanyl was not counted for as the pca showed that the patient pushed the button zero times however the syringe was empty.Additionally there was no basal rate coming off the pca syringe as the patient had a separate bag that was running outside of the pca for his basal dose.Customer stated that they are unclear as to what happened and is requesting a log review.There was no reported patient harm.
 
Event Description
It was reported from the pediatric unit that a fentanyl pca was set-up for one initial bolus and subsequent patient-initiated dosing only.The patient received an initial bolus of 7.5 ml of fentanyl (75 mcg of a 10 mcg/ml 50 ml syringe).After 2 hours it appeared that the entire 500mcg of fentanyl was not counted for as the pca showed that the patient pushed the button zero times however the syringe was empty.Additionally there was no basal rate coming off the pca syringe as the patient had a separate bag that was running outside of the pca for his basal dose.Customer stated that they are unclear as to what happened and is requesting a log review.There was no reported patient harm.
 
Manufacturer Narrative
Omit: a1402 - excess flow or over-infusion (1311), b21 - type of investigation not yet determined, c21 - results pending completion of investigation, d16 - conclusion not yet 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,d codes, 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.Per 803.52(f)(11)(iii) the information provided represents all of the known information at this time.H3 other text : not applicable.Device evaluated by bd.
 
Manufacturer Narrative
Omit: a0507 - mechanics altered (2984), g04063 - handpiece, c19 - no device problem found, c0402 - incompatible component/ accessory.Additional information: imdrf annex a, imdrf annex c, imdrf annex g codes.
 
Event Description
It was reported from the pediatric unit that a fentanyl pca was set-up for one initial bolus and subsequent patient-initiated dosing only.The patient received an initial bolus of 7.5 ml of fentanyl (75 mcg of a 10 mcg/ml 50 ml syringe).After 2 hours it appeared that the entire 500mcg of fentanyl was not counted for as the pca showed that the patient pushed the button zero times however the syringe was empty.Additionally there was no basal rate coming off the pca syringe as the patient had a separate bag that was running outside of the pca for his basal dose.Customer stated that they are unclear as to what happened and is requesting a log review.There was no reported patient harm.
 
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Brand Name
ALARIS SYSTEM
Type of Device
INFUSION PUMP
Manufacturer (Section D)
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 Key11918871
MDR Text Key254101111
Report Number2016493-2021-53525
Device Sequence Number1
Product Code MEA
UDI-Device Identifier10885403912002
UDI-Public(01)10885403912002
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,Company Representative
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup,Followup
Report Date 04/25/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/02/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number8120
Device Catalogue Number8120 ALARIS PCA MODULE
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/02/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/10/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/15/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
8015
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