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

Catalog Number 2C2009K

Device Problem Filling Problem (1233)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/22/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that a large volume infusor under infused.It was further reported that approximately 50ml of drug solution remained after disconnection.The device had been filled with fluorouracil.This issue was identified after patient use.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Additional information was added to d9, h3, h4 and h6.H4: the lot was manufactured from september 09, 2020 - september 10, 2020.H10: the device was received for evaluation.Visual inspection using the naked eye did not identify any abnormalities that could have contributed to the reported condition.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: INFUSOR
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 11343680
• MDR Text Key: 232831664
• Report Number: 1416980-2021-00720
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 00085412579399
• UDI-Public: (01)00085412579399
• 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: 03/11/2021

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: Health Professional
• Device Catalogue Number: 2C2009K
• Device Lot Number: 20J007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2021
• Initial Date Manufacturer Received: 01/25/2021
• Initial Date FDA Received: 02/18/2021
• Supplement Dates Manufacturer Received: 03/03/2021
• Supplement Dates FDA Received: 03/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FLUOROURACIL