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

Catalog Number 2C4702K

Device Problem Short Fill (1575)

Patient Problem Underdose (2542)

Event Date 06/04/2014

Event Type  malfunction  

Event Description

It was reported that a small volume folfusor underinfused.This occurred during infusion of 5 g/100 ml of fluorouracil.The device was filled with 96 ml of solution and was expected to infuse for 48 hours.The reporter stated that about 75% of the fill volume remained at the end of the infusion.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

(b)(4).(b)(6).The lot 14a061 was manufactured between january 30, 2014 to january 31, 2014.A batch review was conducted and revealed that all of the acceptance criteria were met to release the lot.Evaluation summary: the actual device was evaluated.Visual inspection of the device did not reveal any abnormalities that could have contributed to the reported condition.A functional flow rate testing was performed and the device was found within specification.The cause of the condition could not be determined.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 - IRVINE; 17511 armstrong avenue; bldg 3; irvine CA 92614
• Manufacturer (Section G): BAXTER HEALTHCARE - IRVINE; 17511 armstrong avenue; bldg 3; irvine CA 92614
• Manufacturer Contact: christina arnt ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242703198
• MDR Report Key: 3901408
• MDR Text Key: 18064690
• Report Number: 1416980-2014-20778
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/04/2014

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 Expiration Date: 01/01/2016
• Device Catalogue Number: 2C4702K
• Device Lot Number: 14A061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/04/2014
• Initial Date FDA Received: 06/30/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: FLUOROURACIL (PFIZER)
• Patient Age: 51 YR
• Patient Weight: 80