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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 Break (1069); Contamination (1120); No Device Output (1435); Failure to Read Input Signal (1581); Mechanics Altered (2984); Appropriate Term/Code Not Available (3191)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
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.
 
Event Description
It was reported that the device failed preventive maintenance for leak test.No additional information was provided.There was no patient involvement.
 
Manufacturer Narrative
A review of the complaint history record in trackwise and sap was performed for the sn (b)(6) which did not confirm similar complaints with the same or related failure mode for this customer.Based on the findings, service determined that the probable root cause of the reported issue was due to electrical failure of the bd assy oridion etco2 v1 rohs.This device was evaluated and repaired through the service repair process.Upon visual inspection the service technician noted that they replaced oridion pcb for failed leak test during pm, 3rd party rear, contaminated left iui and etco2 door for won't close/stuck.The failure code othe 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 28jan2014.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 sn (b)(6) was performed which confirmed that this device was not involved in a production failure which correlates to the customer reported issue.
 
Event Description
It was reported that the device failed preventive maintenance for leak test.No additional information was provided.There was no patient involvement.
 
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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 Key11593070
MDR Text Key243096197
Report Number2016493-2021-501739
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
Report Date 03/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
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 Manufacturer03/19/2021
Initial Date Manufacturer Received 03/16/2021
Initial Date FDA Received03/30/2021
Supplement Dates Manufacturer Received06/30/2021
Supplement Dates FDA Received07/01/2021
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberZ-2722-2020
Patient Sequence Number1
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