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

Model Number 8300

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The customer¿s concerns for an unknown error was confirmed during testing.Testing performed on the returned etco2 module in the ¿as received¿ condition showed that when the device is attached to a test pcu, the device immediately alarms for a ¿system error¿ code 9-100-1318.Tracker (b)(4) was opened to investigate the error code 9-100-1318.The error is the result of an invalid model number.The source etco2 module event log confirmed the device had a model and serial number of ¿0¿ (zero).The model number and serial numbers were corrected using flash tools.Further testing confirmed the issue could also be resolved using asm test software.Attempts were made to replicate a ¿0¿ model and serial number; however, testing failed to replicate the anomaly by entering ¿0¿ in the model field.It is believed the device encountered software corruption.As a precaution the service will replace the logic board and calibration before returning the device to the customer.Based on the logs, there was no patient involvement.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 returned for servicing which correlates to the customer reported issue.A review of the complaint history record in the trackwise was performed for the sn (b)(4) which confirmed no similar complaints with the same or related failure mode.The customer stated that there was patient involvement.

Event Description

It was reported that there were four etco2 devices that malfunctioned.It is unknown which of the four devices malfunctioned during patient use, therefore, the customer is sending in all four devices for investigational purposes.The etco2 device alarmed for "error-unknown".

• 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: sujitha jayaraman ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 11093363
• MDR Text Key: 224298594
• Report Number: 2016493-2020-84711
• 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: company representative,other
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 09/18/2019

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2019
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/13/2017
• 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
• Treatment: CAD_ETCO2_DISP,8015,CAD_PCA_TUBE,8120.