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

Catalog Number 2C4705K

Device Problem No Flow (2991)

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

Event Type  malfunction  

Manufacturer Narrative

B3: event date and d10: concomitant product (1): therapy date^: the event dates were from(b)(6) 2024 to (b)(6) 2024.(b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that there was no fluid flow through four (4) small volume folfusors.This issue was further described as, ¿minimal flow rate noticed, and the little change in the balloon size¿.These occurred during patient infusion.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Additional information was added to h3, h4, h6, and h10: h4: the lot was manufactured between august 16, 2023 ¿ august 17, 2023.H10: the actual device was not available; however, four (4) companion samples were received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported no flow.A functional flow rate test was performed on the samples, and the flow rates were found to be within the product specification range.During the flow test, evidence of continuous flow of fluid was observed flowing out of the distal luer.Based on the evaluation result, the companion samples were determined to be conforming products.The reported condition was not verified.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: 18873895
• MDR Text Key: 337306907
• Report Number: 1416980-2024-01037
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 00085412081588
• UDI-Public: (01)00085412081588
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2C4705K
• Device Lot Number: 23H010
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/13/2024
• 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: DESFERRIOXAMINE; SODIUM CHLORIDE