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

Catalog Number 2C4009K

Device Problems Excess Flow or Over-Infusion (1311); Device Displays Incorrect Message (2591)

Patient Problem Overdose (1988)

Event Type  malfunction  

Event Description

It was reported that a large volume folfusor overinfused.The reporter stated that "the pump delivered the contents too fast.¿ there was no patient injury or medical intervention reported.No additional information is available.

Manufacturer Narrative

(b)(4).The device has been received and the evaluation is in progress.Upon completion of the device evaluation, or if any additional relevant information is received, a supplemental report will be submitted.

Manufacturer Narrative

(b)(4).Manufacture date - january 9, 2014 ¿ january 10, 2014.Evaluation summary: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was received for evaluation with 118 ml of fluid within its bladder.The device label states that fluorouracil and 0.9% sodium chloride were used in the device.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.A functional flow rate test revealed that the flow rate was within specification.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: 3917572
• MDR Text Key: 4491586
• Report Number: 1416980-2014-21772
• 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: 06/12/2014

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: 01/01/2016
• Device Catalogue Number: 2C4009K
• Device Lot Number: 14A003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/14/2014
• Initial Date FDA Received: 07/07/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/07/2014
• 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: Unknown
• Patient Sequence Number: 1