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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION SD ALARIS ET CO2 MODULE; ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS
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CAREFUSION SD ALARIS ET CO2 MODULE; ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS Back to Search Results
Model Number 8300
Device Problems Excess Flow or Over-Infusion (1311); Device Sensing Problem (2917)
Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
No device will be returned per customer.The customer complaint could not be confirmed because the device was not returned for failure investigation.The root cause of this failure was not identified.
 
Event Description
It was reported that the customer answered yes to the following survey questions: "are you aware of any events associated with an interruption of communication or power between pc unit and modules?" and "is there any apparent damage or corrosion to the iui connector?" there was no patient involvement reported.
 
Manufacturer Narrative
No device history search was performed since no source device serial number was reported by the customer.A review of the march 2021 complaint review board (crb) did not find an increasing trend for the reported issue of "iui damage or corrosion" based on the crb review and the limited information provided no further investigation actions will be performed.The root cause of the customer¿s complaint of iui damage or corrosion could not be confirmed, as no product was returned for investigation.The reported issue of iui damage or corrosion could not be confirmed, as no product was returned for investigation.No further investigation of this event is possible at this time.The device is used for treatment purposes.No product returned.
 
Event Description
It was reported that the customer answered yes to the following survey questions: "are you aware of any events associated with an interruption of communication or power between pc unit and modules?" and "is there any apparent damage or corrosion to the iui connector?" there was no patient involvement reported.
 
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Brand Name
ALARIS ET CO2 MODULE
Type of Device
ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS
Manufacturer (Section D)
CAREFUSION SD
10020 pacific mesa blvd
san diego CA 92121 4386
MDR Report Key11330024
MDR Text Key231989139
Report Number2016493-2021-26148
Device Sequence Number1
Product Code CCK
Combination Product (y/n)N
PMA/PMN Number
K031741
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 10/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/15/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number8300
Device Catalogue Number8300
Was Device Available for Evaluation? No
Date Manufacturer Received10/30/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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