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

Catalog Number D2C4704K

Device Problem No Flow (2991)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the flow of a folfusor sv (small volume) was ¿restricted¿.The device had been filled with 5-fluorouracil.This issue was identified during patient use.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

H4: the lot was manufactured from october 3, 2019 - october 4, 2019.H10: the device was received for evaluation containing approximately 34ml of fluid in the bladder.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.After the luer cap was removed, evidence of continuous flow was visually observed at the distal luer.A functional flow rate test was performed and the flow rate was found to be within the product specification range.The reported condition was not verified.The device was found to be conforming product.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: 11095780
• MDR Text Key: 224408449
• Report Number: 1416980-2020-08194
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 00085412474267
• UDI-Public: (01)00085412474267
• 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: 02/02/2021

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: D2C4704K
• Device Lot Number: 19K001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2021
• Initial Date Manufacturer Received: 12/07/2020
• Initial Date FDA Received: 12/30/2020
• Supplement Dates Manufacturer Received: 01/28/2021
• Supplement Dates FDA Received: 02/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 5-FLUOROURACIL; 5-FLUOROURACIL