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

Catalog Number 2C4063K

Device Problem Material Split, Cut or Torn (4008)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the line of a large volume folfusor snapped.This occurred while the patient was sleeping.The device was filled with piperacillin/tazobactam13.5g plus citrate buffer in 230ml sodium chloride.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

H4: device manufacture date: the lot was manufactured from january 19, 2023, to january 25, 2023.H10: the actual device was not available; however, a photograph of the sample was provided for evaluation.A visual inspection of the photograph provided noted that the tubing line was cut in two pieces.When the photo images were zoomed in, the cut mark appeared to be jagged and not smooth, which suggested the tubing line may have been stuck between two objects; then the user tried to pull the stuck tubing line away from the two objects and therefore resulted in the tubing line being broken in two pieces.The reported condition was verified.The cause of the condition could not be determined.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: 17230403
• MDR Text Key: 318570261
• Report Number: 1416980-2023-03242
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 00085412080161
• UDI-Public: (01)00085412080161
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2C4063K
• Device Lot Number: 23A026
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/21/2023
• 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
• Treatment: CITRATE BUFFER; PIPERACILLIN/TAZOBACTAM; SODIUM CHLORIDE