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

Model Number 8300

Device Problems Break (1069); Crack (1135); No Device Output (1435); Mechanics Altered (2984); Naturally Worn (2988)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

This reported event and any subsequent repairs have been investigated through the normal service repair process.Failure data and parts used information, was reviewed for the sap file and track wise file, and found to be relevant to the service repair.A review of the source device service history record was performed beginning from the date of manufacture to the present date.Service returns were for unrelated issues.The database showed no quality notifications were opened for the source device.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 and product was returned for the 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.Capa reference: (b)(4).The customer stated that there was no patient involvement.

Event Description

(b)(4).This unit was rur in previous notification (b)(4) due to unresponsive customer.Device will be estimated for fail leak down test and need to replace oridion pcb.Crack front case and after market rear case.Submitted for customer approval for major repair.(b)(4).

• 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: naveen balaji kumar ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 10545164
• MDR Text Key: 221311014
• Report Number: 2016493-2020-05794
• 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
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 01/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2020
• 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?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/18/2008
• 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