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

Catalog Number 2C4063K

Device Problems Fluid/Blood Leak (1250); Material Rupture (1546)

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

Event Date 03/15/2023

Event Type  malfunction  

Manufacturer Narrative

E1: initial reporter phone no.(b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the bladder of a large volume folfusor burst and fluid leaked from the bladder onto the plastic outer container.The patient noticed condensation on the container of the device.The device had been filled with flucloxacillin 8g plus citrate buffer in 230ml sodium chloride 0.9%.Once the patient noticed the leak they did not connect the device for infusion.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

H4: device manufactured on october 6, 2022-october 7, 2022.H10: the actual device was not available; however, a photograph of the sample was provided for evaluation.A visual inspection was performed to the photograph using the naked eye which revealed that droplets of fluid were inside the device housing; particularly on the inner wall of the housing.Due to the nature of the sample, no additional tests could be performed.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: 16692138
• MDR Text Key: 312866159
• Report Number: 1416980-2023-01603
• 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,Consumer,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 2C4063K
• Device Lot Number: 22K010
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/04/2023
• 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.; FLUCLOXACILLIN.; SODIUM CHLORIDE.
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 117 KG