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

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.

• 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 Key: 11340868
• MDR Text Key: 232332145
• Report Number: 2016493-2021-26410
• Device Sequence Number: 1
• Product Code: CCK
• UDI-Device Identifier: 10885403830013
• UDI-Public: 10885403830013
• Combination Product (y/n): N
• PMA/PMN Number: K031741
• Number of Events Reported: 1
• 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 Received: 02/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8300
• Device Catalogue Number: 8300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2021
• Date Manufacturer Received: 04/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-2722-2020
• Patient Sequence Number: 1