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

Model Number 8300 ALARIS ETCO2 MODULE

Device Problem Failure to Calibrate (2440)

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

Event Type  malfunction  

Manufacturer Narrative

This event was inadvertently reported under incorrect product registration number (manufacturer report number 9616066-2020-02903).This mdr resubmission now reflects the correct product registration number.This reported event and subsequent repairs were investigated through the service repair process.Failure data and parts-used information were reviewed for the sap and track wise files and found relevant to the service repair.A review of the source device service history record was performed from the date of manufacture to the date corresponding to this service notification number.The database showed no quality notifications were opened for the device.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

(b)(4).Report failed gas check during the device check in process was confirmed.Failed gas leak isolated to the device process issue.Recommend service to perform full calibration and check in process.No repair is required.

Event Description

Fails co2 sensor calibration & accuracy- (b)(6)2018 09:31:54 (b)(6).No charge oob / repair (b)(6)2018 09:48:20 (b)(6).Device run time is o.5 hrs.And it meets the criteria to be re-stocked per doc.(b)(4) out-of-box failure processing.(b)(6)2018 09:56:08 (b)(6).Report failed gas check during the device check in process was confirmed.Failed gas leak isolated to the device process issue.Recommend service to perform full calibration and check in process.No repair is required.

Manufacturer Narrative

Addition: updated adverse event codes (h6).

• 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: 16046132
• MDR Text Key: 308472810
• Report Number: 2016493-2022-1179091
• Device Sequence Number: 1
• Product Code: CCK
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/16/2018

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 ALARIS ETCO2 MODULE
• Device Catalogue Number: 8300 ALARIS ETCO2 MODULE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/16/2018
• Initial Date FDA Received: 12/25/2022
• Supplement Dates Manufacturer Received: 05/16/2018
• Supplement Dates FDA Received: 03/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/21/2017
• 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