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

Catalog Number 2C4711K

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Type  malfunction  

Event Description

It was reported that some white powder was observed in a small volume folfusor.The device was filled with fluorouracil 3950mg in 115ml sodium chloride.This occurred prior to patient use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

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

Manufacturer Narrative

H4: the lot was manufactured between august 18, 2023- august 21, 2023.H10: the actual device was received for evaluation containing drug fluid in the bladder.Visual inspection identified several small white specks of drug powder located on the outer surface of the device.A functional leak test was performed by adding green color water to the bladder.The device was being monitored until the next day and no evidence of leak was observed.The reported condition was verified.The cause of the condition could not be determined; however, the most probable cause was due to user error.During the filling step, drops of drug fluid may have inadvertently dropped onto the outer surface of the device bottle and overtime, the drug fluid dried up into powder form.The drug powder came from the drug fluid, not from the folfusor device.The device was determined to be a conforming product.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: 18607261
• MDR Text Key: 335076226
• Report Number: 1416980-2024-00238
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 00085412082172
• UDI-Public: (01)00085412082172
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/28/2024

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: Other
• Device Catalogue Number: 2C4711K
• Device Lot Number: 23H012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 01/05/2024
• Initial Date FDA Received: 01/30/2024
• Supplement Dates Manufacturer Received: 02/04/2024
• Supplement Dates FDA Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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