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

Catalog Number D2C4063K

Device Problems Fluid/Blood Leak (1250); Material Deformation (2976)

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

Event Type  malfunction  

Manufacturer Narrative

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 large volume folfusor leaked at the distal connection.It was further stated that a deformed distal connection was detected, the closure wing cap could not be placed closing.This issue was discovered after filling with saline.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Additional information was added to h3, h4, h6 and h10.H10: the device was received for evaluation.A visual inspection was done which observed the flow restrictor has been damaged.Further inspection showed evidence of teeth marks (diagonal lines) located on the flow restrictor body and on the blue winged luer cap body which suggested the cause of damage may be related to the flow wrap sealer equipment used during manufacturing when the folfusor sample was leak tested, evidence of leak was observed coming out at the damaged the flow restrictor body.The reported condition was verified.The cause of the condition was due to a manufacturing issue.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: 13153140
• MDR Text Key: 283604011
• Report Number: 1416980-2021-07637
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 00085412474335
• UDI-Public: (01)00085412474335
• 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: 01/28/2022

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: Other
• Device Catalogue Number: D2C4063K
• Device Lot Number: 21F043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/24/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/08/2021
• Initial Date FDA Received: 01/04/2022
• Supplement Dates Manufacturer Received: 01/13/2022
• Supplement Dates FDA Received: 01/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/24/2021
• 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
• Treatment: NA.