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

Catalog Number 2C4711K

Device Problem Filling Problem (1233)

Patient Problem Diarrhea (1811)

Event Date 02/06/2024

Event Type  Injury  

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 over infused.The expected infusion time was 46 hours; however, after 24 hours the device was noticed to be empty.The patient experienced gi issues (diarrhea) on the same day the infusion began and was hospitalized on an unknown date.The patient is currently admitted to rehabilitation and patient outcome at the time of this report is unknown.The device contained 4632mg fluorouracil in 0.9% sodium chloride.No further information was available at the time of this report.

Manufacturer Narrative

Additional information: h4, h6, h10.H4: the lot was manufactured between june 2, 2023 and june 6, 2023.H10: 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.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: 18952664
• MDR Text Key: 338270679
• Report Number: 1416980-2024-01263
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 00085412082172
• UDI-Public: (01)00085412082172
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 04/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2C4711K
• Device Lot Number: 23F002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/21/2024
• Initial Date FDA Received: 03/21/2024
• Supplement Dates Manufacturer Received: 04/11/2024
• Supplement Dates FDA Received: 04/18/2024
• 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; SODIUM CHLORIDE
• Patient Outcome(s): Hospitalization