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

Catalog Number 2C1009KP

Device Problems Excess Flow or Over-Infusion (1311); Positioning Problem (3009)

Patient Problem Overdose (1988)

Event Date 04/30/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This lot was manufactured between november 26, 2013 and november 27.Evaluation summary: baxter received one unit for evaluation.Visual inspection showed no signs of physical abnormality.A functional flow rate test was performed on the unit and was found to be within specification.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 a large volume infusor overinfused.The reporter stated that the device was filled with fluorouracil and was expected to fully deliver its contents in 46 hours, but the infusion was completed in 34 hours.The patient stated that they were not in a shower or heated area, the device was around their neck, and they slept on their side all night.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

(b)(4).The device was returned and is currently in the process of being evaluated.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: INFUSOR
• 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: 3851071
• MDR Text Key: 16816480
• Report Number: 1416980-2014-17976
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K071222
• 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: 05/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/01/2016
• Device Catalogue Number: 2C1009KP
• Device Lot Number: 13M091
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/30/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/27/2013
• 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: FLUOROURACIL