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

Catalog Number 2C4702K

Device Problem Fluid/Blood Leak (1250)

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

Event Date 04/09/2024

Event Type  malfunction  

Manufacturer Narrative

E1: initial reporter facility name: (b)(6).E1: initial reporter address: (b)(6).Civils de lyon/ 57 rue francisque darcieux bp should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a small volume folfusor was leaking from an unspecified location.The device contained chemotherapeutic solution.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

H4: the lot was manufactured between june 14, 2023 - june 16, 2023.H11: the device was received for evaluation.A visual inspection revealed fluid inside the bags that contained the units.When the devices were removed from the bag, the cause of leak inside the bag was found to be untightened winged luer cap from first and second units and detached winged luer cap from the third unit.Signs of surface roughness were not observed inside the caps when inspected under the microscope.A functional leak test was performed by filling the device with green colored water.After filling and prime, to ensure the blue cap was securely connected to the device, the cap was hand tightened by manually rotating the cap until the cap could not be rotated further.The samples were being monitored until the next day and no signs of leak were observed.The reported condition was verified in all three devices.The cause of the condition was due to a user error by not tightening the blue winged cap.The product label (ifu, instructions for use) indicates the winged cap should be securely connected to the device 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: 19216617
• MDR Text Key: 341430285
• Report Number: 1416980-2024-02004
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 00085412080154
• UDI-Public: (01)00085412080154
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: Nurse
• Type of Report: Initial
• Report Date: 04/30/2024

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: Health Professional
• Device Catalogue Number: 2C4702K
• Device Lot Number: 23F009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/09/2024
• Initial Date FDA Received: 04/30/2024
• 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: CHEMOTHERAPEUTIC SOLUTION
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 76 KG