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

Catalog Number 2C2063K

Device Problems Disconnection (1171); Fluid/Blood Leak (1250)

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

Event Date 03/19/2024

Event Type  malfunction  

Event Description

It was reported that a large volume infusor leaked within the sealed overpouch; the blue tip (cap) of the tube was "not connected or not securely closed, was floating in the leaked solution".This was observed at the hospital, prior to patient use.The device contained 4500mg fluorouracil in 0.9% sodium chloride.There was no patient involvement.No additional information is available.

Manufacturer Narrative

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

Manufacturer Narrative

H4: the lot was manufactured between june 26, 2023 ¿ june 27, 2023.H10: the actual device was not available; however, a photograph of the sample was provided for evaluation.Visual inspection of the provided photographic samples showed fluid inside a closed bag that contained the infusor which suggested a leak may have occurred.The reported condition was verified.Also during visual inspection, the blue winged capped was observed detached.Therefore, the cause of the leak was due to a use-error from a detached blue winged luer cap that was not securely connected after filling and priming.Per the product label (ifu, instructions for use), ¿ensure that the winged luer cap is securely connected after filling and priming.¿ 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: 19099580
• MDR Text Key: 340806140
• Report Number: 1416980-2024-01682
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 00085412579412
• UDI-Public: (01)00085412579412
• 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
• Report Date: 04/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2C2063K
• Device Lot Number: 23F032
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/19/2024
• 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