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

Model Number 8100

Device Problems Contamination (1120); Corroded (1131); Communication or Transmission Problem (2896)

Patient Problem Irritability (2421)

Event Date 10/16/2021

Event Type  malfunction  

Manufacturer Narrative

A device history record review is performed on each device reported in a mdr reportable event along with other methods of investigation as coded in this mdr report.Per 803.52(f)(11)(iii) the information provided represents all of the known information at this time.The complainant or reporter was unable or unwilling to provide any further patient, product, or procedural details to the manufacturer.Not applicable.Device evaluated by bd.

Event Description

It was reported precedex was intended to run at 52.5 ml/hr however it was not infusing as the precedex bag was still full.The clinician reported that the patient was becoming agitated and having difficulty ventilating on the ventilator.The customer provided a photo of the devices, the pump module used for precedex infusion was not appearing on the pcu screen while the other 2 pump modules attached to the same pcu did appear on the pcu screen.There was patient involvement but no harm.

• Brand Name: ALARIS SYSTEM
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): CAREFUSION SD; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer Contact: brett wilko ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 13124455
• MDR Text Key: 285255635
• Report Number: 2016493-2021-78556
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 10885403810015
• UDI-Public: (01)10885403810015
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K133532
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 12/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8100
• Device Catalogue Number: 8100 ALARIS LVP MODULE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/24/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/07/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: Z-2718-2020
• Patient Sequence Number: 1