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

Catalog Number 2C4702K

Device Problem Fluid/Blood Leak (1250)

Patient Problems Chemical Exposure (2570); Partial thickness (Second Degree) Burn (2694)

Event Date 08/02/2016

Event Type  Injury  

Manufacturer Narrative

The device was manufactured april 18, 2016 ¿ april 19, 2016.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

A patient experienced a second degree burn due to a leak from a small volume folfusor.The patient was hospitalized to receive treatment for another indication and folfusor was used to deliver an infusion of 5fu (dose and frequency was not reported).During the infusion, leak occurred resulting to a second degree skin burn, characterized by ¿a whitish powder deposit¿, at the infusion site (internal mammary vein).No further detail was provided regarding the volume of the leak, the cause of the leak, required medical intervention or the patient¿s outcome from the event.No additional information is available.

• Brand Name: FOLFUSOR
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): BAXTER HEALTHCARE - IRVINE; irvine CA
• Manufacturer (Section G): BAXTER HEALTHCARE - IRVINE; 17511 armstrong avenue; building 3; irvine CA 92614
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 6424177
• MDR Text Key: 70550626
• Report Number: 1416980-2017-02540
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2019
• Device Catalogue Number: 2C4702K
• Device Lot Number: 16D024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/27/2017
• Initial Date FDA Received: 03/22/2017
• 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: N
• Patient Sequence Number: 1
• Treatment: THE 5FU (FLUOROURACIL, NOT FURTHER SPECIFIED)
• Patient Outcome(s): Other
• Patient Age: 44 YR