MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION FOLFUSOR; PUMP, INFUSION, ELASTOMERIC

Catalog Number 2C4702K

Device Problem Filling Problem (1233)

Patient Problem Diarrhea (1811)

Event Date 09/01/2020

Event Type  Injury  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

A patient experienced an over infusion with a folfusor sv 2ml/hr device which resulted in acute diarrhea.It was reported the solution was delivered within 32 hours instead of the expected 48hours.The device infused fluorouracil solution (92 ml 5 fu; diluent and total volume unreported).The cause of the over infusion was not reported.It was reported the patient was hospitalized for the acute diarrhea event.Treatment for the event was not reported.At the time of this report, the patient was recovered.No additional information is available.

Manufacturer Narrative

A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.The probable cause of the reported event was associated with use error.The folfusor device is a small-volume infusor with a recommended fill volume of 96 ml.The reported total fill volume of 92 ml represents a volume that is lower than that recommended by the manufacturer (user error).As per product labelling and customer training, filling the infusor less than the recommended volume can lead to high flow/ increased rate of delivery.Using a different calibrating diluent other than that recommended by the manufacturer (dextrose 5%) can also affect the flow rate.The type of diluent used was requested but not reported.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: FOLFUSOR
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10705385
• MDR Text Key: 212106943
• Report Number: 1416980-2020-06511
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 00085412080154
• UDI-Public: (01)00085412080154
• Combination Product (y/n): Y
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2023
• Device Catalogue Number: 2C4702K
• Device Lot Number: 20A030
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 5FU; 5FU
• Patient Outcome(s): Hospitalization
• Patient Age: 84 YR