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

Catalog Number 2C4711K

Device Problem Reflux within Device (1522)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

This event occurred during the unspecified date of december 2019.(b)(6).The device was received and is currently awaiting evaluation.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that there was back flow of solution through a small volume folfusor.After filling the device prior to patient use, the diluent solution (glucose 5%) flowed back (reflux) through the point where it was injected with a syringe.There was no patient involvement.No additional information is available.

Manufacturer Narrative

The device was manufactured from august 27, 2019 - august 28, 2019.The actual device was received for evaluation.Functional testing was performed by filling the device with green colored water.During fill, leak/backflow was observed at the fillport.The reported condition was verified.Further evaluation revealed the cause of the leak/backflow was due to a particle measured to be 0.25 square mm in size, lodged under the device checkband.The particle was subsequently identified to be acrylic material via ftir spectroscopy (fourier-transform infrared spectroscopy).The cause was determined to be a manufacturing related issue.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.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
• Manufacturer (Section G): BAXTER HEALTHCARE - IRVINE; 17511 armstrong avenue; building 3; irvine CA 92614
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 9554392
• MDR Text Key: 173935702
• Report Number: 1416980-2019-07409
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 00085412082172
• UDI-Public: (01)00085412082172
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 02/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2022
• Device Catalogue Number: 2C4711K
• Device Lot Number: 19H054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/13/2019
• Initial Date FDA Received: 01/06/2020
• Supplement Dates Manufacturer Received: 01/10/2020
• Supplement Dates FDA Received: 02/04/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1