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

Catalog Number 2C4063K

Device Problem Filling Problem (1233)

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

Event Date 12/04/2022

Event Type  malfunction  

Manufacturer Narrative

Initial reporter facility name: (b)(6) hospital.Additional initial reporter e-mail: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a large volume folfusor overinfused; further described as was infusing too quickly and finished in 12 hours instead of 24 hours.The device was filled with flucloxacillin 8g plus citrate buffer in 230ml sodium chloride 0.9%.This was observed after use of the device.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

The device was connected midline to the upper arm of the patient and stored over the shoulder during the infusion.The flow restrictor was taped to the skin for the entire infusion.The device was manufactured from july 11, 2022 - july 13, 2022.The actual device was received for evaluation.The sample did not contain fluid in the bladder.A visual inspection on the returned sample via the naked eye showed no signs of physical abnormality that could have caused the reported flow problem.A functional flow rate test was performed on the sample and the results were found to be within the product specification range.The reported condition was not verified.The product met specification.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: 16062467
• MDR Text Key: 307888454
• Report Number: 1416980-2022-07113
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/03/2023

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: 22G016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/05/2022
• Initial Date FDA Received: 12/28/2022
• Supplement Dates Manufacturer Received: 02/02/2023
• Supplement Dates FDA Received: 02/03/2023
• 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
• Treatment: CITRATE BUFFER; FLUCLOXACILLIN; SODIUM CHLORIDE
• Patient Sex: Female