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

Model Number 8300

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

A review of the device history record showed the device had a manufacture date of (b)(6) 2013.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.A review of the complaint history record in trackwise and sap was performed for the sn (b)(4) which did not confirm similar complaints with the same or related failure mode for this customer.

Event Description

It was reported that the device had an unknown alarm- error code/ message.No patient involvement.

• Brand Name: 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: shari lynn groth ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 11270468
• MDR Text Key: 243053212
• Report Number: 2016493-2021-22621
• 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: Biomedical Engineer
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 12/07/2020

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: 12/22/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/02/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/08/2013
• 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-2721-2020
• Patient Sequence Number: 1