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

Model Number 8300

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The customer¿s reported problem was confirmed.A review of the device history record in sap for sn (b)(4) was performed from the date of the manufacture to date of the release of product, which confirmed that this device was not involved in a production failure, and product was not returned for servicing which not correlates to the customer reported issue.A trackwise complaint history review was completed, and it was confirmed that there were additional complaints received with similar sn (b)(4) for the same or related failure mode.The customer stated that there was no patient involvement.

Event Description

Case #: (b)(4).Case subject: npi error code 571.6241 on 8300 unit.Account name: (b)(6).Account #: (b)(6).Asset name: 8300 etco2 module, v8 (b)(6).Patient or user involvement: no.Patient or user harm: no.Case description: tech called in for help on 8300 unit serial # (b)(4).Case resolution: per tech when power unit on he gets error code 571.6241 on etco2 unit which has to do with the ecto2 board will need to replace the etco2 board on unit.Tech thank me for my assist.

• 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: karunamoorthy subramani ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 11242781
• MDR Text Key: 231400980
• Report Number: 2016493-2021-19319
• Device Sequence Number: 1
• Product Code: CCK
• UDI-Device Identifier: 10885403830013
• UDI-Public: 10885403830013
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 8300
• Device Catalogue Number: 8300
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2014
• 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