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

Catalog Number 2C4063K

Device Problem Fluid/Blood Leak (1250)

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

Event Date 02/28/2024

Event Type  malfunction  

Event Description

It was reported that a large volume folfusor leaked inside the protective bag.This was observed while unboxing the device.There was no patient involvement.No additional information is available.

Manufacturer Narrative

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

Manufacturer Narrative

Additional information: d4, d9, h3, h4, h6, h10.H4: the lot was manufactured between july 7, 2023 and july 11, 2023.H10: the device was received for evaluation.During visual inspection fluid was observed inside the bag that contained the unit suggesting a leak may have occurred.When the unit was removed from the bag, the cause of leak was found to be a partially broken tubing at the junction of the luer.The reported condition was verified.The cause of the condition could not be determined; however, the most probable cause may be due to how the device was being handled during use.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: 18975545
• MDR Text Key: 338623247
• Report Number: 1416980-2024-01330
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 00085412080161
• UDI-Public: (01)00085412080161
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2C4063K
• Device Lot Number: 23G002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 04/15/2024
• 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.