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

Model Number 8300

Device Problem Charging Problem (2892)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The customer¿s reported problem was confirmed.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 not returned for servicing which not 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

Case #: 00810066 case subject: npi 8300 no power account name: mercy san juan hospital account #: 1470202 asset name: 8300 etco2 module, v8 asset location: contact: mark bautista contact email: mark.Bautista@dignityhealth.Org contact phone: 9162040494 contact mobile: patient or user involvement: no patient or user harm: no case description: customer called reporting no power on their 8300 (sn: (b)(4)).Failure device type: alaris system instrument failure problem type: 8300 failure mode: troubleshooting/ error codes case resolution: customer stated they already replaced the power supply board as directed by technical support.At this point i recommended installing the old power supply board, and send in for repair.Customer will call back with po.Ended call.

• 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: madhavan ezhumalai ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 11045072
• MDR Text Key: 232837654
• Report Number: 2016493-2020-75299
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2020
• 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?: No
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/11/2015
• 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