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

Model Number 8100

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/23/2024

Event Type  malfunction  

Event Description

It was reported that the chemotherapy infusion epoch (etoposide 110 mg + vincristine 0.36 mg + doxorubicin 22 mg) ran longer than expected.A 500ml bag of epoch was expected to run over twenty three hours with the intended rate of 21.5ml/hr.The infusion was programmed as continuous and given in four doses.First bag was hung at (b)(6)2024 at 6:48 pm and delayed by an hour, second bag hung at (b)(6)2024 at 7:50 pm which was delayed by 4 hours and 15 minutes and the third bag on (b)(6)2024 at 12:06am.There was patient involvement but no harm.

Manufacturer Narrative

A follow up report will be submitted once the failure investigation has been completed.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.

Event Description

It was reported that the chemotherapy infusion epoch (etoposide 110 mg + vincristine 0.36 mg + doxorubicin 22 mg) ran longer than expected.A 500ml bag of epoch was expected to run over twenty three hours with the intended rate of 21.5ml/hr.The infusion was programmed as continuous and given in four doses.First bag was hung at 23feb2024 at 6:48 pm and delayed by an hour, second bag hung at 24feb2024 at 7:50 pm which was delayed by 4 hours and 15 minutes and the third bag on 26feb2024 at 12:06am.There was patient involvement but no harm.

Manufacturer Narrative

It was determined through investigation of the returned devices that the initially reported suspect device with serial number# (b)(6) is a concomitant and this file has captured the correct suspect device with serial number# (b)(6) as per investigation report.Omit : concomitant med prod data (8015), b21 - type of investigation not yet determined, c21 - results pending completion of investigation, d16 - conclusion not yet available.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 section h6 of this mdr report.

• Brand Name: ALARIS SYSTEM
• 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: brett wilko ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 18956799
• MDR Text Key: 338317226
• Report Number: 2016493-2024-20873
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 10885403810046
• UDI-Public: (01)10885403810046
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133532
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• 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: 03/19/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/16/2018
• 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
• Treatment: 8015.; 8100.