MAUDE Adverse Event Report: CAREFUSION SD 8300 ETCO2 MODULE V9.33.0; PUMP, INFUSION

Model Number 8300

Device Problem Protective Measures Problem (3015)

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

Event Type  malfunction  

Manufacturer Narrative

A review of the device service history record was performed from the date of manufacture to the present date.The database showed no quality notifications were opened for the device.A review of the device history record showed the device had a manufacture date of 25mar2013.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)(4) was performed which confirmed that this device was not involved in a production failure which correlates to the customer reported issue.A review of the complaint history for sn (b)(4) was performed in bd2 trackwise which did not confirm similar complaints with the same or related failure mode.Capa reference: n/a.The customer stated that there was no patient involvement.Device was not returned to manufacturing facility.

Event Description

Alarm - error codes / (b)(4).The device was not received as of this date.No determinations regarding the reported issue nor those requiring escalation were established.A review of the device service history record was performed from the date of manufacture to the present date.The device was previously returned for service issues unrelated to the reported complaint or service history.The database showed no quality notifications were opened for the device.Based on the file review, a global reportability assessment was not required.The customer stated that there was no patient involvement.No escalation was required per (b)(4).This file was closed because the device was not received within 55 days of opening the file.

Manufacturer Narrative

A review of the device service history record was performed from the date of manufacture to the present date.The database showed no quality notifications were opened for the device.A review of the device history record showed the device had a manufacture date of 25mar2013.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.A review of the complaint history for sn (b)(6) was performed in bd2 trackwise which did not confirm similar complaints with the same or related failure mode.The customer stated that there was no patient involvement.

Event Description

Alarm - error codes / messages- 12/18/2018 08:05:04 rfc_repairs (rfc_repairs) po for $1,625.570.6500 - board safety sys serious mod error the device was not received as of this date.No determinations regarding the reported issue nor those requiring escalation were established.A review of the device service history record was performed from the date of manufacture to the present date.The device was previously returned for service issues unrelated to the reported complaint or service history.The database showed no quality notifications were opened for the device.Based on the file review, a global reportability assessment was not required.The customer stated that there was no patient involvement.No escalation was required per swi 1501-006-000 and 1501-070-000.This file was closed because the device was not received within 55 days of opening the file.

• Brand Name: 8300 ETCO2 MODULE V9.33.0
• 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: 12238090
• MDR Text Key: 265985357
• Report Number: 2016493-2021-511408
• 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: Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/18/2018

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: Other
• Device Model Number: 8300
• Device Catalogue Number: 8300
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/21/2021
• Initial Date FDA Received: 07/28/2021
• Supplement Dates Manufacturer Received: 12/18/2018
• Supplement Dates FDA Received: 12/06/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/25/2013
• 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