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

Catalog Number 2C4711K

Device Problems Fluid/Blood Leak (1250); Material Twisted/Bent (2981)

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

Event Type  malfunction  

Manufacturer Narrative

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 leaked from the connection.This was observed during patient use.The tip appeared crushed.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 h3, h4, h6 and h10.H4: device manufacture date: june 10, 2021 - june 11, 2021.H10: the device was received for evaluation.Visual inspection was performed and noted the flow restrictor body was damaged.Leak was confirmed at the damaged flow restrictor body when the folfusor sample was being leak tested with water.The reported condition was verified.The cause of the condition was due to diagonal indentation lines noted on the flow restrictor body which indicated the flow restrictor may have been damaged by the flow wrap sealer equipment during manufacturing.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 ; 2242702068
• MDR Report Key: 12960841
• MDR Text Key: 281983600
• Report Number: 1416980-2021-07203
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 00085412082172
• UDI-Public: (01)00085412082172
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 01/11/2022

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: Lay User/Patient
• Device Catalogue Number: 2C4711K
• Device Lot Number: 21F034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/15/2021
• Initial Date FDA Received: 12/08/2021
• Supplement Dates Manufacturer Received: 01/02/2022
• Supplement Dates FDA Received: 01/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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