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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION SD ALARIS ETCO2; ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS

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CAREFUSION SD ALARIS ETCO2; ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS Back to Search Results
Model Number 8300
Device Problems Failure to Calibrate (2440); Device Sensing Problem (2917); Appropriate Term/Code Not Available (3191)
Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Although requested, the affected device has not been received.A follow up report will be submitted with investigation results should the device be received for evaluation.
 
Event Description
The customer reported unknown error while performing co2 sensor.There was no patient involvement.
 
Event Description
The customer reported unknown error while performing co2 sensor.There was no patient involvement.
 
Manufacturer Narrative
The affected device has been received and an evaluation is pending.A follow up report will be submitted once the evaluation is completed.The affected device has been received and an evaluation is pending.
 
Manufacturer Narrative
This device was evaluated and repaired through the service repair process.Upon visual inspection the service technician noted failed co2 calibration with error code 570.6200 was confirmed due to a bad oridion board, replaced it with a new oridion board.Also replaced both new iui connectors for their wear.Performed leak down test and co2 calibration with passing results.The failure code other was used to track the alaris pump software version as received from the customer and the software version when device was sent back to the customer.It does not reflect a device failure or represent any risk to the patient.A review of the device history record showed the device had a manufacture date of 22oct2018.The review was performed from the date of manufacture to the date of product release for distribution.A review of the device history record in sap for (b)(6) was performed which confirmed that this device was not involved in a production failure which correlates to the customer reported issue.A review of the complaint history record in trackwise and sap was performed for the (b)(6) which did not confirm similar complaints with the same or related failure mode for this customer.
 
Event Description
The customer reported unknown error while performing co2 sensor.There was no patient involvement.
 
Event Description
The customer reported unknown error while performing co2 sensor.There was no patient involvement.
 
Manufacturer Narrative
Correction: e.2; g.2.This device was evaluated and repaired through the service repair process.Upon visual inspection the service technician noted failed co2 calibration with error code 570.6200 was confirmed due to a bad oridion board, replaced it with a new oridion board.Also replaced both new iui connectors for their wear.Performed leak down test and co2 calibration with passing results.The probable root cause of the reported issue was due to electrical failure of the oridion board - failed co2 cal test (error code 570.6200).A review of the device history record showed the device had a manufacture date of 22oct2018.The review was performed from the date of manufacture to the date of product release for distribution.A review of the device history record was performed which confirmed that this device was not involved in a production failure which correlates to the customer reported issue.A review of the complaint history record in was performed which did not confirm similar complaints with the same or related failure mode for this customer.
 
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Brand Name
ALARIS ETCO2
Type of Device
ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS
Manufacturer (Section D)
CAREFUSION SD
10020 pacific mesa blvd
san diego CA 92121 4386
MDR Report Key11340868
MDR Text Key232332145
Report Number2016493-2021-26410
Device Sequence Number1
Product Code CCK
UDI-Device Identifier10885403830013
UDI-Public10885403830013
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
Remedial Action Recall
Type of Report Initial,Followup,Followup,Followup
Report Date 02/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/17/2021
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? Device Returned to Manufacturer
Date Returned to Manufacturer02/19/2021
Date Manufacturer Received04/14/2021
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberZ-2722-2020
Patient Sequence Number1
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