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

Catalog Number 2C4700K

Device Problem Filling Problem (1233)

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

Event Date 02/27/2024

Event Type  malfunction  

Manufacturer Narrative

E1: initial reporter postal code: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a small volume folfusor underinfused the medication.The fluid to be administered was 84ml of 5-flurouracil 2394mg in glucose 5%.The expected duration of the infusion was 7 days or 168 hours; however, the actual duration or the exact volume of fluid left in the device was unspecified.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Additional information: d9, h3, h4, h6 and h10.H10: the actual device was received for evaluation.A visual inspection was performed and the device had no signs of physical abnormality that could have caused the reported flow problem.A functional flow rate test was performed and the results were found to be within the product specification range.The reported condition was not verified.The device was found to be conforming product during functional testing.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: 18968616
• MDR Text Key: 338489756
• Report Number: 1416980-2024-01303
• Device Sequence Number: 1
• Product Code: MEB
• 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: Foreign,Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2C4700K
• Device Lot Number: 22B031
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/28/2024
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: FLUOROURACIL.; GLUCOSE.