MAUDE Adverse Event Report: CAREFUSION SD 8220 ALARIS SPO2 - MASSIMO; PUMP, INFUSION

Model Number 8220

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

This reported event and subsequent repairs were investigated through the tsc troubleshooting process.A review of the device service history record was performed from the date of manufacture to the date corresponding to this service notification number.The database showed no quality notifications were opened for the device.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 trackwise complaint history review was completed, and it was confirmed that there were additional complaints received with similar sn (b)(4) for the same or related failure mode.The customer stated that there was no patient involvement.

Event Description

(b)(4).8200 400.5040 error.Software compatibility.Biomed was trying to use the 8200 on a 8000 unit.Let biomed know that the software installed on the 8200 is not compatible with the 8000.He will need to a 8015 unit to be able to use this module.Biomed will use a 8015 unit.

• Brand Name: 8220 ALARIS SPO2 - MASSIMO
• 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: vidya kannapiran ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 10915372
• MDR Text Key: 226633011
• Report Number: 2016493-2020-50551
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K010966
• 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: 11/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 8220
• Device Catalogue Number: 8220
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/12/2005
• 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