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

Model Number 8220

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The customer reported problem was confirmed.The device was repaired, passed all required testing and specifications, and released back to the customer.Upon visual inspection the service technician noted that they replaced broken rear case and crack front case.Replaced patient connector pcb for no spo2 reading.Replaced contaminated left iui and broken right iui.Based on the findings, service determined that the proximate cause of the reported issue was due to customer damage of the rear case.Device history review a review of the device history record for sn (b)(4) was performed from date of manufacture 08/09/2012 to the present date 12/15/2020 and confirmed that this device was not previously returned for servicing.Also, there were no production failures indicated on the source device.

Event Description

It was reported that the device had was not reading spo2, had damaged front and rear cases and a damaged port.No patient involvement.

Manufacturer Narrative

Updated d2 - product code.

Event Description

It was reported that the device had was not reading spo2, had damaged front and rear cases and a damaged port.No patient involvement.

• Brand Name: ALARIS SPO2
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): CAREFUSION SD; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 11022887
• MDR Text Key: 232295437
• Report Number: 2016493-2020-70492
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 10885403822018
• UDI-Public: 10885403822018
• Combination Product (y/n): N
• PMA/PMN Number: K010966
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 11/11/2020

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: 8220
• Device Catalogue Number: 8220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/16/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1