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

Catalog Number 2C4009K

Device Problem Material Rupture (1546)

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

Event Date 12/29/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the balloon of a large volume folfusor burst.This occurred before patient use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Additional information was added to d9, h3, h4, h6, and h10: h4: the lot was manufactured between july 5, 2023 ¿ july 7, 2023.H10: the device was received for evaluation.A visual inspection was performed, and it was noted that there was fluid inside the bag that contained the unit.When the unit was removed from the bag, the cause of leak inside the bag was found to be an untightened red luer cap.The red luer cap is not a baxter product.The customer did not use the folfusor's blue winged luer cap; therefore, the cause of leak inside the bag was due to a use error.No evidence of rupture was observed from the bladder.The bladder was in normal condition.A functional leak test was performed, with no issues noted.Based on the sample analysis finding, the folfusor unit was determined to be conforming product.The reported condition of a ruptured bladder was not verified; however, a leak was discovered due to a user error.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: 18740939
• MDR Text Key: 335813844
• Report Number: 1416980-2024-00670
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2C4009K
• Device Lot Number: 23G001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2024
• 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
• Treatment: NA.