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

Catalog Number D2C4711K

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

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that ¿an oily film that appears to run down the inside the pump¿ was observed in a small volume folfusor.This occurred prior to patient use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

H4: the device was manufactured from july 10, 2019 - july 12, 2019.H10: the actual device was received for evaluation.A visual inspection was performed using the naked eye which revealed traces of silicone oil located on the interior wall of the housing.Silicone oil is used during the manufacturing process and therefore, is not considered a particulate or foreign matter.Occasionally, silicone oil can drip on the interior wall of the housing; this condition is cosmetic and has no impact on the functionality nor safety of the product.Therefore, the reported condition of particulate matter was not verified.A functional testing was not performed for this complaint.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: 9532640
• MDR Text Key: 173204401
• Report Number: 1416980-2019-07261
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 02/05/2020

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: D2C4711K
• Device Lot Number: 19G020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2020
• Initial Date Manufacturer Received: 12/05/2019
• Initial Date FDA Received: 12/30/2019
• Supplement Dates Manufacturer Received: 01/17/2020
• Supplement Dates FDA Received: 02/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1