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

Catalog Number 2C4702K

Device Problem No Flow (2991)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

It was reported that the event occurred on an unknown day in (b)(6) of 2021.Initial reporter postal code: (b)(6).The device has been received and the evaluation is in progress.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a small volume folfusor did not flow.This occurred prior to patient use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Additional information was added to h3, h4 and h6.H4: the lot was manufactured from september 01, 2020 - september 02, 2020.H10: the device was received containing 99 ml of fluid in the bladder.Visual inspection using the naked eye did not identify any abnormalities that could have contributed to the reported condition.After the luer cap was removed, evidence of continuous flow of fluid was observed coming out at the distal luer.A functional flow rate test was performed and the results were within the product specification range.The reported condition was 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: 11350780
• MDR Text Key: 232835152
• Report Number: 1416980-2021-00755
• 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: 03/18/2021

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: 2C4702K
• Device Lot Number: 20J030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2021
• Initial Date Manufacturer Received: 01/25/2021
• Initial Date FDA Received: 02/19/2021
• Supplement Dates Manufacturer Received: 02/21/2021
• Supplement Dates FDA Received: 03/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1