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

Catalog Number D2C4063K

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 03/10/2024

Event Type  malfunction  

Event Description

It was reported an unspecified particulate was observed on the tubing of a large volume folfusor when adding 0.9% sodium chloride (nacl).There was no patient involvement.No additional information is available.

Manufacturer Narrative

E1: initial reporter address: (b)(6).E 1: initial reporter phone no.: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

Additional information was added to d4, d9, h3, h4, h6, and h11: correction: d10 (also, update date to n/a).H4: the lot was manufactured between may 8, 2023 ¿ may 9, 2023.H11: the device was received for evaluation.A visual inspection via the naked eye was performed, and a reddish-brown particle embedded in the material of the tubing line was observed.The particle was not in the fluid path because it was embedded in the material of the tubing line.A fourier transform infrared spectroscopy (ftir) was performed, and the material was identified to be a mixture of polyvinyl chloride (pvc) and phthalate material which is the same material as the tubing line.The reported condition was verified.The cause of the particulate was from a fragment of burnt pvc material during manufacturing.However, the particle is unlikely to cause harm and does not impact the sterile pathway.The particle outside of the fluid path does not impact the product delivered to the patient.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: 19207973
• MDR Text Key: 341370404
• Report Number: 1416980-2024-01959
• 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: 05/31/2024

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: 23E007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/05/2024
• Initial Date FDA Received: 04/29/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/01/2024
• 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
• Treatment: SALINE SOLUTION