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

Catalog Number 2C4009K

Device Problem Overfill (2404)

Patient Problem Overdose (1988)

Event Date 02/11/2014

Event Type  malfunction  

Event Description

It was reported that over infusion was observed in a large volume folfusor at the end of infusion of 3600mg fluorouracil in 0.9% sodium chloride solution.There is no report of patient/user injury or medical intervention was needed in association with this event.No additional information is available.

Manufacturer Narrative

(b)(4).A batch review will be performed.One used infusor sample was received containing no fluid in the bladder.Visual inspection of the infusor sample shows no signs of physical abnormality that could have caused the reported problem.A functional flow rate test was subsequently conducted on the infusor sample for 43.5 hours.At the end of the flow test period, the flow rate was found to be within the specification range of the product.Based on the evaluation finding, the reported condition was not confirmed.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

(b)(4).The reporter stated that the infusor infused in 18 hours instead of the expected 46 hours.Lot 13n010 was manufactured december 10, 2013 - december 11, 2013.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 - 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: 3670830
• MDR Text Key: 4346156
• Report Number: 1416980-2014-08050
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 02/13/2014

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: Other
• Device Expiration Date: 12/01/2015
• Device Catalogue Number: 2C4009K
• Device Lot Number: 13N010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/17/2014
• Initial Date FDA Received: 03/10/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/02/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 3600MG FLUOROURACIL IN 0.9% SODIUM CHLORIDE; 158 ML 0.9% SODIUM CHLORIDE