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

Catalog Number 2C4711K

Device Problem Fluid/Blood Leak (1250)

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

Event Date 03/04/2024

Event Type  malfunction  

Event Description

It was reported that a small volume folfusor leaked from an unspecified location.This was observed during preparation by a nurse.There was no patient involvement.No additional information is available.

Manufacturer Narrative

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

Manufacturer Narrative

Additional information was added to d4: expiration date, d9, h3, h4, h6, and h10: h4: the lot was manufactured between january 23, 2023 ¿ january 24, 2023.H10: the device was received for evaluation.A visual inspection was performed via the naked eye, and fluid inside a bag that contained the unit was observed.When the unit was removed from the bag, an untightened winged luer cap was found; the cap¿s thread was visible.Signs of surface roughness were not observed inside the cap when inspected under the microscope.A functional leak test was performed and the unit was monitored until the next day; no signs of leak were observed.The reported condition was verified during visual inspection; however, not verified during functional testing.The cause of the leak could not be determined; however, may be related to user error by not securely tightening the winged luer cap.The product label (ifu, instructions for use) instructs the user to ensure the 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: 18993011
• MDR Text Key: 338933490
• Report Number: 1416980-2024-01401
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 00085412082172
• UDI-Public: (01)00085412082172
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2C4711K
• Device Lot Number: 23K014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2024
• 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.