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

Catalog Number 2C4063K

Device Problems Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)

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

Event Date 03/21/2024

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that flow restrictor separated from the tubing of a large volume folfusor and the entire contents of the folfusor leaked into the protective bag.This was noticed while emptying the shipping box before use.There was no patient involvement.No additional information was available.

Manufacturer Narrative

H4: the lot was manufactured between august 1, 2023 and august 3, 2023.H10: the device was received for evaluation.A visual inspection was performed, and it was noted that there was fluid inside the bag that contained the unit which suggested a leak.Further inspection revealed the cause of the leak was due to broken tubing at the solvent-bonded junction of the flow restrictor.The remnant of broken tubing remained inside the solvent-bonded area of the flow restrictor.The morphology of the end of the broken tubing and internal sites of the breakage suggested there was extra solvent present which caused melting of the tubing.The melting likely decreased the integrity of the tubing, causing breakage to occur.The reported condition was verified.The cause of the reported condition was a manufacturing issue.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: 19116043
• MDR Text Key: 340750395
• Report Number: 1416980-2024-01711
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 2C4063K
• Device Lot Number: 23H001
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/21/2024
• 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