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

Catalog Number 2C4702K

Device Problems Fluid/Blood Leak (1250); No Flow (2991)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/01/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that a folfusor sv (small volume) ¿was leaking during connection to the patient¿.The leak was ¿at level of implantable chamber¿.On the following day after the device was connected to the patient, ¿leaks like white crystals under dressing at the connection¿ were observed.It was further stated that the ¿folfusor did not infuse at all¿.As a result, the device was disconnected from the patient.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 august 03, 2020 - august 04, 2020.H10: the device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Further inspection was performed which observed a non-baxter connector that was securely attached to the flow restrictor.The non-baxter connector was disconnected, and baxter's blue winged cap was securely connected to the flow restrictor.A functional leak testing was performed with baxter's blue winged cap connected and no evidence of leakage was observed which indicated the cause of leak was from the non-baxter connector and not from the folfusor device flow restrictor.Based on the evaluation finding, baxter's folfusor device was determined to be conforming product.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: 11091791
• MDR Text Key: 224762774
• Report Number: 1416980-2020-08180
• 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: 02/01/2021

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: 2C4702K
• Device Lot Number: 20H032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2021
• Initial Date Manufacturer Received: 12/04/2020
• Initial Date FDA Received: 12/29/2020
• Supplement Dates Manufacturer Received: 01/13/2021
• Supplement Dates FDA Received: 02/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1