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

Catalog Number 2C4063K

Device Problem Chemical Spillage (2894)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

It was reported that a large volume folfusor experienced a leaked during filling with an unknown antibiotic.The leak location was observed to be at the level of the cap coil.There was no patient involvement.Additional information was requested and is not available.

Manufacturer Narrative

(b)(4).The exact date of occurrence is unknown; however, the event did occur on an unknown date in (b)(6) 2014.Sample was received and the evaluation is in progress.Upon completion of baxter's investigation, if additional relevant information is obtained, a follow-up will be submitted.

Manufacturer Narrative

(b)(4).The device was manufactured march 10, 2014 ¿ march 11, 2014.Evaluation summary: the actual device was received for evaluation with approximately 250ml of fluid in its bladder.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.A function leak test was performed by filling the unit with water.During and after fill, no evidence of a leak was observed at the level of the coil cap or on other parts of the unit.The next day, there was still no evidence of a leak observed.No nonconformances were found during the evaluation.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: 3853879
• MDR Text Key: 4679430
• Report Number: 1416980-2014-18178
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 05/14/2014

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: 03/01/2016
• Device Catalogue Number: 2C4063K
• Device Lot Number: 14C005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/30/2014
• Initial Date FDA Received: 06/06/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/28/2014
• 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