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

Catalog Number 2C1009KP

Device Problem Scratched Material (3020)

Patient Problem No Patient Involvement (2645)

Event Date 09/30/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 a large volume infusor had a long scratch on the stressmember.The scratch was from the stressmember plug, approximately an inch long with fiber like threads coming from it.The device was filled with fluorouracil.There was no patient involvement.No additional information is available.

Manufacturer Narrative

(b)(4).The device was manufactured april 7, 2015 - april 8, 2015.The device was received for evaluation.Visual inspection on the returned unit via the naked eye noted a line approximately 10.15 mm in length located on the stressmember.Examination of the line under the microscope showed the line was actually molded within the material of the stressmember and does not affect the device.The reported condition was not 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: INFUSOR
• 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: 5154507
• MDR Text Key: 28722050
• Report Number: 1416980-2015-39116
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K071222
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 04/01/2018
• Device Catalogue Number: 2C1009KP
• Device Lot Number: 15D014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/22/2015
• 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: N
• Patient Sequence Number: 1