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

Catalog Number 2C4711K

Device Problems Disconnection (1171); Fluid/Blood Leak (1250)

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

Event Date 07/11/2023

Event Type  malfunction  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that two (2) small volume folfusors leaked.Both infusors had large amounts of white powder residue around the blue connector.The blue connector detached from one of the infusors and liquid began to leak until the connector was reattached.This was discovered prior to patient use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Additional information was added to b5, h3, h4, h6 and h10.B5: the devices contained fluorouracil 3900 mg in 115 ml total volume in sodium chloride 0.9% bp.H4: device manufactured on april 22, 2023- april 25, 2023.H10: the actual devices were not available; however, photographs were provided for evaluation.A visual inspection was performed to the photographs using the naked eye which revealed fluid inside a yellow bag that contained the device; which suggested a leak occurred.The photos also showed white drug residue located at the connection of the blue winged luer cap which suggested a leak may have occurred at the connection of the blue winged luer cap.Due to the nature of the sample, no additional tests were performed.The reported condition was verified.The cause of the condition could not be determined from the photographs.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: 17442813
• MDR Text Key: 320222788
• Report Number: 1416980-2023-03873
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 00085412082172
• UDI-Public: (01)00085412082172
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: N/A
• 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: 09/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2023
• 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: 23D015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/30/2023
• Was Device Evaluated by Manufacturer?: No
• 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