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

Model Number 8120

Device Problems Electrical /Electronic Property Problem (1198); Material Separation (1562)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Although requested, device has not been received.A follow up report will be submitted with failure investigation results should the device be received for evaluation.

Event Description

It was reported that during routine preventative maintenance biomed noticed that the keypad was separating from the pca front case.There was no patient involvement.

Manufacturer Narrative

Correction: please disregard file.After further review, the file is now deemed as non-reportable malfunction.

Event Description

It was reported that during routine preventative maintenance, biomed noticed that the keypad was separating from the pca front case.There was no patient involvement.

• Brand Name: ALARIS PCA MODULE
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): CAREFUSION SD; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 11279574
• MDR Text Key: 230294014
• Report Number: 2016493-2021-22503
• Device Sequence Number: 1
• Product Code: MEA
• UDI-Device Identifier: 10885403812002
• UDI-Public: 10885403812002
• Combination Product (y/n): N
• PMA/PMN Number: K043299
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 01/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8120
• Device Catalogue Number: 8120
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1