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

Catalog Number D2C4063K

Device Problem Fluid/Blood Leak (1250)

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

Event Type  malfunction  

Event Description

It was reported that a large volume folfusor leaked.This was observed after production, when the device was released.The device contained 2.35mg yondelis.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

E1: initial reporter facility name: (b)(6).E1: initial reporter address: (b)(6).E1: initial reporter phone no: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

Additional information: d9, h3, h4, h6, h10 h4: the lot was manufactured between may 8, 2023 - may 9, 2023.H10: the actual device was received for evaluation.Upon receipt, visual inspection on the unit via the naked eye noted 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 winged luer cap.Signs of surface roughness were not observed inside the cap when inspected under the microscope.Therefore, the cause of leak may be due to a use error by not securely tightening the winged luer cap.A functional leak test was performed with ensuring the winged luer cap is securely connected to the device, and there were no signs of a leak.Based on the sample analysis finding, the device was determined to be conforming product because no evidence of leak was observed during the functional leak test.The reported condition was verified.The cause of the reported condition was a user error.The product label (ifu, instructions for use) indicates, ¿ensure that the winged luer cap is securely connected after filling and priming¿.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: 18837881
• MDR Text Key: 336904129
• Report Number: 1416980-2024-00926
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 00085412474335
• UDI-Public: (01)00085412474335
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 04/10/2024

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: D2C4063K
• Device Lot Number: 23E007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/08/2024
• Initial Date FDA Received: 03/05/2024
• Supplement Dates Manufacturer Received: 03/21/2024
• Supplement Dates FDA Received: 04/10/2024
• 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: YONDELIS