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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 Contamination (1120); Crack (1135); Insufficient Flow or Under Infusion (2182); Failure to Calibrate (2440); Component Misassembled (4004)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/02/2024
Event Type  malfunction  
Event Description
It was reported that there was an under infusion of doxorubicin.At 0707, day 3, cycle 3 doxorubicin was set to infuse at 20.8 ml/hour with a volume to be infused of 500ml.The following day at 0654, the pump indicated 5.1ml to be infused.However, the clinician noted approximately 100ml remaining in the bag.It was noted the "pump would beep occasionally then restart".The pump and pcu were changed and the remainder of the infusion was administered on the new pump.Patient continued chemotherapy protocol.This incomplete infusion delayed the next scheduled chemotherapy infusion by approximately 4 hours.There was patient involvement but no harm.
 
Manufacturer Narrative
A follow up report will be submitted once the failure investigation 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.
 
Event Description
It was reported that there was an under infusion of doxorubicin.At 0707, day 3, cycle 3 doxorubicin was set to infuse at 20.8 ml/hour with a volume to be infused of 500ml.The following day at 0654, the pump indicated 5.1ml to be infused.However, the clinician noted approximately 100ml remaining in the bag.It was noted the "pump would beep occasionally then restart".The pump and pcu were changed and the remainder of the infusion was administered on the new pump.Patient continued chemotherapy protocol.This incomplete infusion delayed the next scheduled chemotherapy infusion by approximately 4 hours.There was patient involvement but no harm.
 
Manufacturer Narrative
Omit: b21 - type of investigation not yet determined, c21 - results pending completion of investigation, d16 - conclusion not yet available, 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 Key18824958
MDR Text Key336738649
Report Number2016493-2024-17992
Device Sequence Number1
Product Code FRN
UDI-Device Identifier10885403810015
UDI-Public(01)10885403810015
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 Administrator/Supervisor
Remedial Action Recall
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 Received03/04/2024
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 Returned to Manufacturer02/28/2024
Date Manufacturer Received02/09/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/20/2006
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Removal/Correction NumberZ-2718-2020
Patient Sequence Number1
Treatment
8015.; 8100 (3).
Patient Age43 YR
Patient Weight86 KG
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