MAUDE Adverse Event Report: CAREFUSION SD 8120 ALARIS PCA; PUMP, INFUSION

Model Number 8120

Device Problem Mechanics Altered (2984)

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 not performed because the serial number was not provided for the suspect device.A dhr (device history record) review cannot be completed as the serial number was not obtained upon receipt of the complaint.Additionally, a historical review of complaints in trackwise cannot be conducted.The customer stated that there was no patient involvement.

Event Description

(b)(4) had a pca 8120.It kept saying calibration required even the calibration was completed.Failure device type: alaris system instrument.Failure problem type: 8120.Failure mode: troubleshooting/ error codes.Case resolution: i advised thai to perform preventive maintenance on the pca.That will address the "calibration required" message.(b)(4) will complete preventive maintenance on the pca.If he still have any issue, he will call me back.

• Brand Name: 8120 ALARIS PCA
• 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: tejas deshmuk ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 10979677
• MDR Text Key: 231108696
• Report Number: 2016493-2020-62584
• Device Sequence Number: 1
• Product Code: MEA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043299
• 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: 04/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 8120
• Device Catalogue Number: 8120
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: Yes
• 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