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

Catalog Number 2C4700K

Device Problems Filling Problem (1233); Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/04/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).The device was received and is currently awaiting evaluation completion.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a small volume folfusor underinfused and the device was observed to be expired after patient infusion.The device had been filled with 1900.5 mg 5-fluorouracil and 50.58 ml diluent sodium chloride to a total fill volume of 88.59ml.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Additional information was added to h3, h4 and h6.H4: the lot was manufactured between may 14, 2016 - may 16, 2016.H10: the actual sample was received for evaluation containing 81ml of fluid in the bladder.Visual inspection performed using the naked eye did not identify any abnormalities that could have contributed to the reported condition.The product pouch insert which was supplied with the product has the product expiration date labeled as may 01, 2019.The product carton box also has the product expiration labeled as may 01, 2019.A functional flow rate test was performed and the flow rate was found to be within the product specification range.The device was determined to be conforming product.The reported conditions were not verified.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
• MDR Report Key: 10359461
• MDR Text Key: 201508757
• Report Number: 1416980-2020-04655
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): Y
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2C4700K
• Device Lot Number: 16E028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2020
• Initial Date Manufacturer Received: 07/08/2020
• Initial Date FDA Received: 08/03/2020
• Supplement Dates Manufacturer Received: 08/11/2020
• Supplement Dates FDA Received: 09/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FLUOROURACIL; SODIUM CHLORIDE