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

Model Number 8300

Device Problems Crack (1135); No Device Output (1435); Appropriate Term/Code Not Available (3191)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The customer reported problem was confirmed.The device was repaired, passed all require testing and specifications and released back to the customer.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

Failed preventive maintenance- (b)(4).Failed leak down test.Oridion board- failed leak down test.Case front- damaged/cracked.Case rear- damaged/cracked.

Event Description

Failed preventive maintenance- (b)(4).Failed leak down test.Oridion board- failed leak down test.Case front- damaged/cracked.Case rear- damaged/cracked.

Manufacturer Narrative

The customer reported problem was confirmed.The device was repaired, passed all require testing and specifications and released back to the customer.A review of the device history record in sap for sn (b)(6) was performed from the date of the manufacture to date of the release of product, which confirmed that this device was 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)(6) which confirmed no similar complaints with the same or related failure mode.The customer stated that there was no patient involvement.

• 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: tukaram bharkad ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 11250279
• MDR Text Key: 230776244
• Report Number: 2016493-2021-20176
• 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
• Type of Report: Initial,Followup
• Report Date: 07/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2021
• 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
• Date Manufacturer Received: 07/09/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/21/2010
• 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