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

Catalog Number 2C4009K

Device Problem Fluid/Blood Leak (1250)

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

Event Date 12/04/2023

Event Type  malfunction  

Event Description

It was reported that up to ten (10) large volume folfusors leaked cytostatic drug from the filling port.This was observed when the devices were unwrapped, before patient use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

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

Manufacturer Narrative

H4: the lot was manufactured between november 21, 2022 ¿ november 22, 2022.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.

Manufacturer Narrative

Additional information was added to b5, d4: expiration date, d9, h3, h6 (update b17 to b01, c20 to c19, d15 to d14), and h10.B5: per additional information, the quantity of impacted large volume folfusors was not specified.H10: one (1) actual device was received for evaluation with fluid in the bladder.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.The non-baxter red luer cap was observed to be securely tightened.A functional leak test was performed by filling the device with green color water to the nominal volume.During fill, no evidence of leak was observed.After fill, the device was being monitored until the next day and no signs of leak were observed.The reported condition was not verified.The device was determined to be conforming product.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: 18414058
• MDR Text Key: 331631059
• Report Number: 1416980-2023-06813
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 00085412080130
• UDI-Public: (01)00085412080130
• 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,Followup
• Report Date: 03/20/2024

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: 2C4009K
• Device Lot Number: 22M013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/04/2023
• Initial Date FDA Received: 12/28/2023
• Supplement Dates Manufacturer Received: 01/25/2024; 02/26/2024
• Supplement Dates FDA Received: 01/31/2024; 03/20/2024
• 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.