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

Model Number 8300

Device Problem Failure to Cycle (1142)

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

The customer reported channel error 571.6241.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.

Event Description

The customer reported channel error 571.6241.There was no patient involvement.

Event Description

The customer reported channel error 571.6241.There was no patient involvement.

Manufacturer Narrative

This device was evaluated and repaired through the service repair process.Upon visual inspection the service technician noted the rear case was dented at left side (bottom), indicated that it was dropped or bumped caused loose ferrite cable on power pcb and subsequently error 571.6241.Reconnected cable from oridion pcb to j3 of power pcb.Replaced broken rear case and front case.Replaced right iui.Performed pm.A review of the device history record showed the device had a manufacture date of 10/09/2017.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.Based on the findings, service determined that the proximate cause of the reported issue was due to loose ferrite cable on power pcb - reconnected (error code 571.6241).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.There are capa #'s noted for the following parts replaced that have an already existing capa ca-2018-0161 iui conn issues.

• 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: 11135304
• MDR Text Key: 238136172
• Report Number: 2016493-2021-03881
• 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,other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 12/14/2020

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: 12/18/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/07/2021
• Supplement Dates Manufacturer Received: Not provided; 12/31/2020
• Supplement Dates FDA Received: 01/28/2021; 04/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-2722-2020
• Patient Sequence Number: 1