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

Catalog Number 2C4711K

Device Problem Material Integrity Problem (2978)

Patient Problem No Patient Involvement (2645)

Event Date 11/25/2016

Event Type  malfunction  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the tubing of a folfusor had a "knick out of the tubing".The infusor was compounded with fluorouracil.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Device manufacture date: june 30, 2016 ¿ july 5, 2016.The device was received for evaluation.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Functional flow rate testing was performed and passed successfully with no issues relating to the reported condition.The reported condition was not verified.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; bldg 3; irvine CA
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 6189107
• MDR Text Key: 62851001
• Report Number: 1416980-2016-18551
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2C4711K
• Device Lot Number: 16F058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/17/2017
• 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