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

Model Number 8210

Device Problems Display Difficult to Read (1181); Display or Visual Feedback Problem (1184)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

No product returned.Because no device or device logs were returned or expected to be returned, no failure investigation could be performed.The root cause of the customer's experience was not identified.H3 other text : only display boards were provided for the investigation.

Event Description

It was reported that the 8210 had dim segments and needed to be replaced.There was no patient involvement.

Manufacturer Narrative

Customers received notification of the field action.The reported issue of a dim segment is confirmed based on the field action.Device repair or returns are handled within the scope of the field action.H3 other text : device was not returned to manufacturing facility.

Event Description

It was reported that the 8210 had dim segments and needed to be replaced.There was no patient involvement.

• Brand Name: ALARIS SPO2 - MASSIMO
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): CAREFUSION SD; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 10988474
• MDR Text Key: 231911549
• Report Number: 2016493-2020-64315
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 10885403821011
• UDI-Public: 10885403821011
• Combination Product (y/n): N
• PMA/PMN Number: K022677
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 11/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8210
• Device Catalogue Number: 8210
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/10/2020
• Supplement Dates Manufacturer Received: 02/11/2021
• Supplement Dates FDA Received: 05/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-2826-2020
• Patient Sequence Number: 1