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

Catalog Number 2C4702K

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/09/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that a small volume folfusor had "completely disassembled" after use of the device.The device had been filled with 5-fluorouracil.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 d10, h3, h4 and h6.H4: the lot was manufactured from may 28, 2020 - may 29, 2020.H10: the device was received for evaluation.Visual inspection was performed which observed that the yellow coil cap was separated from the housing.The reported condition was verified.The cause of the condition was not determined; however, the most likely cause is manufacturing related.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: 10722525
• MDR Text Key: 212690656
• Report Number: 1416980-2020-06567
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 00085412080154
• UDI-Public: (01)00085412080154
• 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: 11/24/2020

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: 2C4702K
• Device Lot Number: 20E051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2020
• Initial Date Manufacturer Received: 09/25/2020
• Initial Date FDA Received: 10/22/2020
• Supplement Dates Manufacturer Received: 11/09/2020
• Supplement Dates FDA Received: 11/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 5-FLUORURACIL