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

Catalog Number 2C1702KP

Device Problem Chemical Spillage (2894)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/24/2014

Event Type  malfunction  

Event Description

It was reported that a small volume infusor leaked.This occurred after the device was filled with fluorouracil and before patient connection.The leak was noticed as the user was placing the device in a septobox container, which already contained a luer lock syringe with a bolus of 500 mg fluorouracil.The reporter stated that approximately 6 ml of solution leaked from what seemed to be the end of the administration tubing, near the cap.The solution came in contact with the user¿s hand; however, there was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

(b)(4).(b)(6).A request for the return of the device has been made.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

(b)(4).The lot was manufactured from april 16, 2014 to april 18, 2014.The device was discarded; therefore, an evaluation could not be conducted.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 follow up 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: 3972974
• MDR Text Key: 4752777
• Report Number: 1416980-2014-25011
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K071222
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/09/2014

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: 04/01/2017
• Device Catalogue Number: 2C1702KP
• Device Lot Number: 14D030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/07/2014
• Initial Date FDA Received: 08/01/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/31/2014
• 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
• Patient Age: 48 YR