MAUDE Adverse Event Report: CAREFUSION SD 8300 ALARIS ETCO2 MODULE; PUMP, INFUSION

Model Number 8300 ALARIS ETCO2 MODULE

Device Problems Loose or Intermittent Connection (1371); Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Type  malfunction  

Event Description

Problem description (b)(4).(b)(6).Spec 1, complaint mgmt, complaint management.Upon power the unit, the biomed saw a 571.6241 error.Recommend to remove the rear case and check the harness to the oridion module.This may become misaligned if the unit is dropped and cause the 571.6241 error.If harness is aligned, then send unit in for warranty first year repair.Biomed will check harness and send in if error persists.

Manufacturer Narrative

This reported event and subsequent repairs were investigated through the tsc troubleshooting process.A review of the device service history record was not performed because the serial number was not provided for the suspect device.A dhr (device history record) review cannot be completed as the serial number was not obtained upon receipt of the complaint.Additionally, a historical review of complaints in trackwise cannot be conducted.The customer stated that there was no patient involvement.Device was not returned to manufacturing facility.

• Brand Name: 8300 ALARIS ETCO2 MODULE
• Type of Device: PUMP, INFUSION
• 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: 12907021
• MDR Text Key: 281513600
• Report Number: 2016493-2021-555169
• Device Sequence Number: 1
• Product Code: CCK
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/1900
• Device Model Number: 8300 ALARIS ETCO2 MODULE
• Device Catalogue Number: 8300 ALARIS ETCO2 MODULE
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/20/2019
• Was Device Evaluated by Manufacturer?: No
• 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