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

Catalog Number 2C4711K

Device Problem Fluid/Blood Leak (1250)

Patient Problems Burn(s) (1757); Skin Discoloration (2074); Skin Irritation (2076); No Consequences Or Impact To Patient (2199)

Event Date 06/17/2015

Event Type  malfunction  

Event Description

It was reported that a small volume folfusor leaked from the flow restrictor while being opened to administer a chemotherapy drug.The device contained ¿3252 mg 5-fu (fluracedyl 5000 mg /100 ml van teva) = 65ml 5-fu, added with 50 ml glucose to have a fill volume of 116 ml¿.The nurse opened the twist-off and fluid squirted out of the flow-regulator onto the nurse¿s face and neck, afterwards the nurse had red skin with blisters with no open injury.Flamigel was applied to the affected area.No additional information is available.

Manufacturer Narrative

(b)(4).Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

(b)(4).The lot was manufactured from march 18, 2015 to march 19, 2015.One actual unit was received for analysis.Visual inspection showed no signs of physical abnormality that could have caused the reported condition.A functional leak test was performed by manually filling the unit with green colored water.During fill and the next day, no evidence of a leak was found on any parts of the unit.No evidence of a leak was found when the fillport cap and blue winged luer cap were twisted off.The reported condition could not be verified.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: kinga almasan ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 4929619
• MDR Text Key: 6031700
• Report Number: 1416980-2015-29683
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/30/2015

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: Health Professional
• Device Expiration Date: 03/01/2017
• Device Catalogue Number: 2C4711K
• Device Lot Number: 15C038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/30/2015
• Initial Date FDA Received: 07/21/2015
• 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