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); 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 device service history record was performed beginning from the date of manufacture to the present date and indicated that this device has been previously returned for service.Service returns were for issues similar to the reported complaint or similar to the service history.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).

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 device service history record was performed beginning from the date of manufacture to the present date and indicated that this device has been previously returned for service.Service returns were for issues similar to the reported complaint or similar to the service history.The database showed no quality notifications were opened for the source device.A review of the device history record in sap for sn (b)(6) 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)(6) which confirmed no similar complaints with the same or related failure mode.Capa reference : ca-2018-0171.The customer stated that there was no patient involvement.

Event Description

Possible oridion board issue.Oridion board- failed leak down test, case rear- damaged/cracked and iui- isolation rib damage.There was no patient involvement.01/19/201,8 08:16:49, (b)(6).Po for (b)(6) approved by (b)(6).Shipping & billing addresses confirmed.01/26/2018, 13:52:03 (b)(6).(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
• MDR Report Key: 10591001
• MDR Text Key: 222164778
• Report Number: 2016493-2020-13379
• Device Sequence Number: 1
• Product Code: CCK
• Combination Product (y/n): N
• PMA/PMN Number: K031741
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 01/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2020
• 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
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1