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

Model Number 8100

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problem Insufficient Information (4580)

Event Date 02/06/2024

Event Type  malfunction  

Event Description

It was reported under infusion events described as chemo ¿running longer¿ and pharmacy is ¿overfilling the bag¿.It happens with all chemo, but gave examples of mtx and cisplatin.Lines are primed with chemo, clinicians input the total volume, press start and then subtract 30ml for the flush and so the line does not run dry (all chemos on a primary line).Once the infusion is complete nurses use a port on the side of the tubing to push a flush syringe into the bag and then program their flush.This was reported to bd representatives during their site visit.There was patient involvement but unknown outcome.

Manufacturer Narrative

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.

• 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: 18806210
• MDR Text Key: 336539225
• Report Number: 2016493-2024-17849
• Device Sequence Number: 1
• Product Code: FRN
• 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: Nurse
• Type of Report: Initial
• Report Date: 02/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2024
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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