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

Model Number 8300

Device Problem Insufficient Information (3190)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The reported issue that the etco2 modules failed calibration due to a board failure, receiving error code 570.6200 could not be confirmed; no product or device logs were returned for investigation.The file was opened to document the issue that was reported.The file was opened to document the issue that was reported.No further investigation of this event is possible at this time.No device history or qn search was performed since no source device serial number was reported by the customer.The issue was reported to have occurred during the pm process and was not involved with any patient incident.The etco2 module is used for patient monitoring during treatment.The file may be closed based on the above facts.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 patient involvement.

Event Description

It was reported that the etco2 modules failed calibration due to a board failure, receiving error code 570.6200.The customer confirmed that there was no patient involvement as error was found during preventive maintenance.The facility recently acquired the modules in (b)(6) 2019.

• 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: prabhu somu ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 11093303
• MDR Text Key: 225103726
• Report Number: 2016493-2020-83044
• Device Sequence Number: 1
• Product Code: CCK
• 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
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 10/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• 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
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• 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