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

Catalog Number 2C4063K

Device Problem Filling Problem (1233)

Patient Problems Fever (1858); Malaise (2359)

Event Date 10/21/2023

Event Type  Injury  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a large volume folfusor underinfused medication which resulted in the patient experiencing fever and malaise.The device delivered the medication dose slower than expected.The patient was hospitalized and received unspecified treatment for this event.The patient¿s outcome was not reported.The device was filled with piperacillin/tazobactam 18000mg in 230ml sodium chloride 0.9%.No additional information is available.

Manufacturer Narrative

Device manufacture date: march 17-21, 2023 the actual device was not available; however, a photograph of the sample was provided for evaluation.Visual inspection of the photo showed residual fluid inside the device's bladder.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: 18159992
• MDR Text Key: 328403888
• Report Number: 1416980-2023-05999
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 12/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2C4063K
• Device Lot Number: 23C025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/22/2023
• Initial Date FDA Received: 11/17/2023
• Supplement Dates Manufacturer Received: 12/07/2023
• Supplement Dates FDA Received: 12/14/2023
• 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 PH 6.5; PIPERACILLIN/TAZOBACTAM; SODIUM CHLORIDE 0.9% SOLUTION
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 55 YR