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

Catalog Number D2C4702K

Device Problem No Flow (2991)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Initial reporter address: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a large volume infusor "could not be left in".It was not specified when in the process step this occurred.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

A1: remove unknown and change to none a2, a3, a4, a5, a6: remove ni and change to na.B5: the product involved was a folfusor (initially reported as a large volume infusor).The issue was further described as: ¿during the production of a 5-fu pump (fluorouracil), the pump is pre-filled with nacl (sodium chloride) and let in.The filled nacl has not "run" into the hose as usual.Nothing came through.¿ as a result, the production was stopped and restarted with a new pump.The issue was identified during set up/preparation (received updated product information and further description of the event).D1: brand name: remove: infusor.D4: catalogue #: remove 2c1009k.D4: lot #: remove 20f025.D4: unique identifier (udi) #: remove (b)(4).D10: concomitant product: remove ni and date asku: change to n/a.H4: the device was manufactured from july 7, 2020 - july 8, 2020.H6 impact code: remove f26 and change to f27.H10: the actual device was received for evaluation.Visual inspection was performed using the naked eye which did not identify any abnormalities that could have contributed to the reported condition.A functional flow rate test was performed and the results were found to be 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
• Manufacturer (Section G): BAXTER HEALTHCARE - IRVINE; 17511 armstrong avenue; building 3; irvine CA 92614
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 16070609
• MDR Text Key: 308246288
• Report Number: 1416980-2022-07152
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 00085412474366
• UDI-Public: (01)00085412474366
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/21/2023

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: D2C4702K
• Device Lot Number: 20G025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/30/2022
• Initial Date FDA Received: 12/29/2022
• Supplement Dates Manufacturer Received: 02/16/2023
• Supplement Dates FDA Received: 02/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1