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

Catalog Number 2C4009K

Device Problems Fluid/Blood Leak (1250); Material Split, Cut or Torn (4008)

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

Event Type  malfunction  

Manufacturer Narrative

E1: initial reporter address: (b)(6).E1: initial reporter city: (b)(6).H4: the lot was manufactured february 10, 2023 - february 14, 2023.H10: the device was received for evaluation.Visual inspection was performed and a broken syringe tip stuck inside the folfusor's fill port was observed.The syringe tip is not a baxter product.Further inspection of the device noted a segment on the tubing line has been damaged.A leak was observed on the damaged area when the folfusor sample was leak tested.The reported condition was verified.Indentation marks from the manufacturing flow wrap sealer equipment were observed on the damaged area of the tubing line which suggested the cause of damage was related to manufacturing.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.

Event Description

It was reported that a large volume folfusor leaked from the tubing.The tubing was observed to have been cut.This occurred during filling prior to patient use.There was no patient involvement.No additional information is available.

• 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: 18355907
• MDR Text Key: 331194131
• Report Number: 1416980-2023-06609
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 00085412080130
• UDI-Public: (01)00085412080130
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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
• Report Date: 12/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2C4009K
• Device Lot Number: 23B006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/24/2023
• 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