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

Catalog Number 2C4711K

Device Problems Leak/Splash (1354); Chemical Spillage (2894)

Patient Problem No Patient Involvement (2645)

Event Date 04/11/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Lot number 14b023 was manufactured february 4, 2014 ¿ february 5, 2014.Evaluation information: the device was not available for evaluation; however, a picture was provided by the customer.A photographic inspection identified that the device was leaking.The cause of malfunction could not be determined without further investigation of the sample.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a folfusor elastomeric device leaked.According to the report, this event occurred at the compounding facility, though it is unknown whether or not this occurred during filling.The solution contained inside of the device reservoir was fluorouracil (5000 mg / 100 ml) and sodium chloride 0.9% (1000ml).There was no patient involvement.No additional information is available.

Manufacturer Narrative

(b)(4).Upon completion of baxter's investigation, if additional relevant information is obtained, 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: 3789414
• MDR Text Key: 11931043
• Report Number: 1416980-2014-14368
• 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: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/11/2014

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: 02/01/2016
• Device Catalogue Number: 2C4711K
• Device Lot Number: 14B023
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/30/2014
• Initial Date FDA Received: 05/05/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/24/2014
• Was Device Evaluated by Manufacturer?: No
• 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