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

Catalog Number 2C4711K

Device Problem Leak/Splash (1354)

Patient Problem Injury (2348)

Event Type  Injury  

Manufacturer Narrative

Initial reporter address: (b)(6).The device was received and is currently awaiting evaluation.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the bladder of small volume folfusor ruptured which resulted in a leak of chemotherapy medication.This event occurred during patient infusion of fluorouracil based chemotherapy agent.The chemotherapy medication leaked externally and came in contact with the patient.Due to the rupture, the patient was not administered a complete therapy.The patient visited the hospital; however, they were not admitted as an in-patient for this event and the patient¿s physician advised to wait for the next planned chemotherapy.No additional information is available.

Manufacturer Narrative

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 evaluated.A visual inspection on the unit via the naked eye showed no evidence of bladder rupture.A functional test was subsequently performed by manually filling the bladder with green colored water.During and after the fill, no evidence of rupture was observed on the device bladder.However, a leak was observed at the solvent-bonded junction of the tubing and the stress member.The cause of leakage was due to manufacturing assembly error.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; 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: 7639708
• MDR Text Key: 112409516
• Report Number: 1416980-2018-03872
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/02/2018

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?: Yes
• Device Operator: Other
• Device Catalogue Number: 2C4711K
• Device Lot Number: 18C058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/30/2018
• Initial Date FDA Received: 06/26/2018
• Supplement Dates Manufacturer Received: 07/12/2018
• Supplement Dates FDA Received: 08/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Other
• Patient Age: 70 YR