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

Catalog Number 2C1155KP

Device Problem Filling Problem (1233)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/24/2014

Event Type  malfunction  

Event Description

It was reported that a large volume infusor experienced an slow infusion.The expected therapy time was 42 hours; however, the device took 66 hours to complete.There was no report of patient injury, medical intervention or adverse event associated with this event.No additional information is available.

Manufacturer Narrative

(b)(4).The device has been received and the evaluation is in progress.Upon completion of the investigation, or if any additional relevant information is received, a supplemental report will be submitted.

Manufacturer Narrative

(b)(4).The device was manufactured april 25, 2014 - april 26, 2014.Evaluation summary: the device was received for evaluation.The label on the device revealed that the device had been filled with fluorouracil in saline solution.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.A functional flow rate test was performed, and the device¿s flow rate was found to be within specification.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: 4354517
• MDR Text Key: 5140687
• Report Number: 1416980-2014-47056
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• PMA/PMN Number: K011317
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Type of Report: Initial,Followup
• Report Date: 11/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/01/2017
• Device Catalogue Number: 2C1155KP
• Device Lot Number: 14D056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2014
• Date Manufacturer Received: 01/07/2015
• 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: Unknown
• Patient Sequence Number: 1