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

Catalog Number 2C2009K

Device Problem No Flow (2991)

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

Event Date 08/20/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that a large volume infusor "stopped working" (no flow).The issue occurred patient infusion.The device was filled with fluorouracil hs (ebewe) 4750mg in 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

H4: device manufacture date: the lot was manufactured from september 16, 2022 to september 20, 2022.H10: the actual device was not available; however, a photograph of the sample was provided for evaluation.A visual inspection of the photograph showed residual fluid inside the device's bladder which suggested a no flow issue may have occurred.The reported condition was verified.The cause of the condition could not be determined as a physical sample was not returned.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: INFUSOR
• 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: 17740921
• MDR Text Key: 323406273
• Report Number: 1416980-2023-04638
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 00085412579399
• UDI-Public: (01)00085412579399
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 10/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2C2009K
• Device Lot Number: 22J014
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/11/2023
• 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: FLUOROURACIL HS (EBEWE); SODIUM CHLORIDE