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

Catalog Number 2C4711K

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Patient Involvement (2645)

Event Date 12/16/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).The device was manufactured between 27aug2019 and 28aug2019.The actual device was not available; however, a photograph of the sample was provided for evaluation.During visual inspection of the picture, fluid was observed inside the device housing; however, the exact location of the leak could not be determined.The reported condition was verified.The cause of the condition could not be determined.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.

Event Description

It was reported during filling with a non-baxter syringe, the complete small volume folfusor "got separated into pieces".It was reported that fluid was "leaking out of the bladder", however; it was further specified that the bladder was not ruptured.There was no patient involvement.No additional information is available.

• Brand Name: FOLFUSOR
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• 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: 9581448
• MDR Text Key: 174742860
• Report Number: 1416980-2019-07521
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 00085412082172
• UDI-Public: (01)00085412082172
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 01/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2022
• Device Catalogue Number: 2C4711K
• Device Lot Number: 19H054
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/17/2019
• 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