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

Catalog Number 2C1008KP

Device Problem Overfill (2404)

Patient Problem Overdose (1988)

Event Date 01/27/2014

Event Type  malfunction  

Event Description

It was reported that a large volume infusor overinfused.The reporter stated that the expected infusion time was 46 hours; however, the device infused between 2 - 9 hours faster than expected.The device was filled with 92 ml fluorouracil in 0.9% sodium chloride.The reporter stated that the flow restrictor was placed approximately 30 cm below the chamber of the device.The device was infusing using a port-a-cath into a subclavian vein in the hemithorax.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

(b)(4).A capa has been opened to address this issue.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

(b)(4).The device was manufactured may 22, 2012 - may 23, 2012.The device was not returned; therefore, a device analysis could not be conducted.This complaint is for a report of a use error where the device was underfilled and not filled to the nominal volume indicated in the direction insert provided with the device.The direction insert for this device states that ¿the infusor lv is designed to flow at the nominal rate indicated on the device when it is filled with a volume ranging from the nominal plus the residual volume to the maximum volume.¿ the direction insert further states that a ¿reduction in fill volume may result in an increased flow rate.¿ 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: christina arnt ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242703198
• MDR Report Key: 3670888
• MDR Text Key: 4241777
• Report Number: 1416980-2014-08056
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K071222
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 02/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/01/2015
• Device Catalogue Number: 2C1008KP
• Device Lot Number: 12E056
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/10/2014
• Initial Date FDA Received: 03/10/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/31/2014
• 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
• Treatment: 92 ML FLUOROURACIL IN 0.9% SODIUM CHLORIDE; PORT-A-CATH