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

Model Number 8300

Device Problems Device Alarm System (1012); Contamination (1120); Loose or Intermittent Connection (1371); Communication or Transmission Problem (2896)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/09/2024

Event Type  malfunction  

Event Description

It was reported that the device had error code 571.6241.There was patient involvement but no harm.Bd has learned additional information.It was reported that masimo disposables are being used with the etco2 modules at the facility.

Manufacturer Narrative

A follow up report will be submitted once the failure investigation has been completed.Per 803.52(f)(11)(iii) the information provided represents all of the known information at this time.The complainant or reporter was unable or unwilling to provide any further patient, product, or procedural details to the manufacturer.

Manufacturer Narrative

Omit: b21 - type of investigation not yet determined, c21 - results pending completion of investigation, d16 - conclusion not yet available.Correction: describe event or problem, fda notified?, report source other, additional information : report source, device eval by manufacturer? , reason code for no evaluation, if other specify , imdrf annex a,g,b,c,d codes and manufacturer narrative.A device history record review is performed on each device reported in a mdr reportable event along with other methods of investigation as coded in section h6 of this mdr report.H3 other text : not applicable.Device evaluated by bd.

Event Description

It was reported that the device had error code 571.6241.There was patient involvement but no harm.Bd has learned additional information.It was reported that masimo disposables are being used with the etco2 modules at the facility.Received a copy of the customer's medwatch report from fda which states, ¿the six alaris etco2 devices that were sent out (three devices returned, waiting on the other three).All six devices had the same verbiage for the problem and repair.Please see below.Error codes 571.6241 is confirmed due to ferrite cable backed off from power supply connector.Reconnected cable from oridion pcb to j3 of power pcb.Performed preventative maintenance with the passed result.The six serial numbers of the down etco2 modules are (b)(6).These devices are four months old, placed in service in june 2023.Six failures of our thirty devices is a 20% failure rate.".

• Brand Name: ALARIS SYSTEM
• Type of Device: ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
• Manufacturer (Section D): CAREFUSION SD; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer (Section G): CAREFUSION SD; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer Contact: brett wilko ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 18621500
• MDR Text Key: 334309570
• Report Number: 2016493-2024-12073
• Device Sequence Number: 1
• Product Code: CCK
• UDI-Device Identifier: 10885403830020
• UDI-Public: (01)10885403830020
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031741
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2024
• 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 ALARIS ETCO2 MODULE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/10/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1