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

Catalog Number 2C4063K

Device Problems Filling Problem (1233); Material Twisted/Bent (2981)

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

Event Date 02/22/2024

Event Type  malfunction  

Event Description

It was reported that the tubing of a large volume folfusor was kinked which resulted in an underinfusion of medication.This occurred during patient infusion via a peripherally inserted central catheter (picc) line.The patient missed the antibiotic dose; after 23 hours of infusion, the device "barely infused".The device contained flucloxacillin 8000mg in 230ml sodium chloride 0.9%.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

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

Manufacturer Narrative

Correction: e4: reporter sent to fda.H4: the lot was manufactured between july 7, 2023 - july 11, 2023.H10: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.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: 18935551
• MDR Text Key: 338080523
• Report Number: 1416980-2024-01215
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 00085412080161
• UDI-Public: (01)00085412080161
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2C4063K
• Device Lot Number: 23G002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/19/2024
• Supplement Dates Manufacturer Received: 04/03/2024
• Supplement Dates FDA Received: 04/16/2024
• 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
• Treatment: FLUCLOXACILLIN; PICC LINE; SODIUM CHLORIDE
• Patient Age: 39 YR