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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 Insufficient Flow or Under Infusion (2182); No Apparent Adverse Event (3189)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/13/2024
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 other text : device was not returned to manufacturing facility.
 
Event Description
It was reported that the patient's second unit of packed red blood cells was hung at 1233.At 1530, while obtaining hourly vitals, the bag of blood appeared fuller than expected to the clinician.The pump stated about 60ml left to infuse out of 300ml, but appeared to be more in bag.Clinician noted the blood was not dripping in the drip chamber.Pump restarted, patient iv patency checked and advanced accessing the needle further into bag.Clinician stayed for an additional 10 minutes to make sure blood was infusing properly.It was noted the pump did not alarm, light remained green and pump stated it was infusing.Patient disconnected from blood at 1626.Provider was notified, cbc was obtained which resulted in a hemoglobin of 8.3g/l.No additional blood was ordered.There was patient involvement but no harm.
 
Event Description
It was reported that the patient's second unit of packed red blood cells was hung at 1233.At 1530, while obtaining hourly vitals, the bag of blood appeared fuller than expected to the clinician.The pump stated about 60ml left to infuse out of 300ml, but appeared to be more in bag.Clinician noted the blood was not dripping in the drip chamber.Pump restarted, patient iv patency checked and advanced accessing the needle further into bag.Clinician stayed for an additional 10 minutes to make sure blood was infusing properly.It was noted the pump did not alarm, light remained green and pump stated it was infusing.Patient disconnected from blood at 1626.Provider was notified, cbc was obtained which resulted in a hemoglobin of 8.3g/l.No additional blood was ordered.There was patient involvement but no harm.
 
Manufacturer Narrative
Omit : c20 - no findings available, d15 - cause not established.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.
 
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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 Key18738580
MDR Text Key335855577
Report Number2016493-2024-14952
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
Reporter Occupation 505
Type of Report Initial,Followup
Report Date 03/19/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/20/2024
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? No
Date Manufacturer Received01/26/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/21/2007
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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