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

Model Number 8300

Device Problems Break (1069); Contamination (1120); Communication or Transmission Problem (2896); Appropriate Term/Code Not Available (3191)

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

Event Type  malfunction  

Manufacturer Narrative

This device was evaluated and repaired through the service repair process.Upon visual inspection the service technician noted that they replaced oridion pcb for error 570.6200.Replaced etco2 door for won't close/stuck.Replaced contaminated left iui.Replaced broken right iui.The failure code othe was used to track the alaris pump software version as received from the customer and the software version when device was sent back to the customer.It does not reflect a device failure or represent any risk to the patient.A review of the device history record showed the device had a manufacture date of 07feb2012.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.Based on the findings, service determined that the probable root cause of the reported issue was due to electrical failure of the oridion board communication failure a review of the complaint history record in trackwise and sap was performed for the sn (b)(4) which confirmed similar complaints with the same or related failure mode for this customer.

Event Description

It was reported that an unknown error occurred with the device.No additional information was provided.There was no patient involvement.

• 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: 12082103
• MDR Text Key: 260028035
• Report Number: 2016493-2021-508752
• Device Sequence Number: 1
• Product Code: CCK
• UDI-Device Identifier: 10885403830020
• UDI-Public: 10885403830020
• 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,health
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 02/05/2021

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: Health Professional
• Device Model Number: 8300
• Device Catalogue Number: 8300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/25/2021
• Initial Date FDA Received: 06/29/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: Z-2722-2020
• Patient Sequence Number: 1
• Patient Outcome(s): Congenital Anomaly