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

Model Number 8120

Device Problem Failure to Analyze Signal (1539)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The customer reported problem was confirmed.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

Case #: (b)(4).Case subject: npi 8120 broken claws account name: (b)(6).Account #: (b)(6).Asset name: 8120 pca module v8 (b)(6).Patient or user involvement: no.Patient or user harm: no.Case description: customer reports broken claws on their 8120 while performing preventative maintenance.Case resolution: informed customer this is most likely due to the linear sensor.Recommended sending in for repair.Emailed customer our fixed level pricing.Customer will send in for repair.Ended call.

• 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: ashin justinthivy ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 11250021
• MDR Text Key: 231984355
• Report Number: 2016493-2021-20260
• 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: 07/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2021
• 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