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

Catalog Number 2C4711K

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 04/19/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).The device was manufactured january 6, 2017 - january 10, 2017.The device was received for evaluation.Visual inspection revealed white drug residue located at the blue winged luer cap.A functional leak test was performed by filling the device with water and manually tightening the blue winged luer cap.The next day, no signs of a leak were observed from the device.The device was found to be within specification.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.

Event Description

It was reported that there was a ¿milky residue¿ inside the outer bag of a small volume folfusor.This was noted when the pharmacist opened the external wrapping, and noticed residue on their gloves after handling the device.The pharmacist reported that there were no visible leaks from the device.The device had been filled with fluorouracil in 0.9% sodium chloride solution to a total fill volume of 115ml.There was no patient involvement.No additional information is available.

• Brand Name: FOLFUSOR
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): BAXTER HEALTHCARE - IRVINE; irvine CA
• 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: 6564905
• MDR Text Key: 75091703
• Report Number: 1416980-2017-04161
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 05/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2020
• Device Catalogue Number: 2C4711K
• Device Lot Number: 17A016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2017
• 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: N
• Patient Sequence Number: 1