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 experience with the etco2 device alarmed for "alarming, reading between 99-00 " was confirmed in the log and replicated during testing and was found to be a ¿etco2 high¿ alarm.The review of the etco2 module event log identified the source device while in use alarming for ¿etco2 high¿.The device continued to alarm until the device malfunction recording a 570.6200.0 (cbit failure) malfunction in the error log.Asm calibration task was performed on the source device.The device failed co2 sensor calibration.The oridion circuit board was then replaced with a known good.The asm calibration task was performed.The device completed calibration and accuracy with no errors.The device was being used for treatment.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 no 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 "alarming, reading between 99-00 ".

• 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: kaarthik surendrababu ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 11101711
• MDR Text Key: 242635826
• Report Number: 2016493-2020-86770
• 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: 09/18/2019

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/31/2020
• 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