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

Model Number 8300

Device Problems Leak/Splash (1354); Failure to Read Input Signal (1581)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The 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 the exhaust leak down test.There was no patient involvement.

Manufacturer Narrative

The investigation is in progress.A follow up report will be submitted once the evaluation is completed.

Event Description

It was reported that the device failed the exhaust leak down test.There was no patient involvement.

Event Description

The customer reported that the device failed the exhaust leak down test.No patient involvement.

Manufacturer Narrative

This device was evaluated and repaired through the service repair process.Upon visual inspection the service technician noted that they failed exhaust leak down test was not confirmed.The device has passed leak down test and co2 calibration with passing results.No fault found.There is another technician that verified the device passed leak down test for the second review.Please verify your disposable tubing test still being in good condition.A review of the device history record showed the device had a manufacture date of 05/08/2019.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.Based on the findings, service was unable to determine the proximate cause of the reported issue.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.There were no existing capa¿s listed for any of the parts listed in this file for repair.

• Brand Name: ALARIS ETCO2 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 Key: 11193904
• MDR Text Key: 227547978
• Report Number: 2016493-2021-14149
• Device Sequence Number: 1
• Product Code: CCK
• UDI-Device Identifier: 10885403830013
• UDI-Public: 10885403830013
• Combination Product (y/n): N
• PMA/PMN Number: K133532
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 01/04/2021

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 Number: 8300
• Device Catalogue Number: 8300
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/15/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/19/2021
• Supplement Dates Manufacturer Received: Not provided; 01/19/2021
• Supplement Dates FDA Received: 02/13/2021; 04/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1