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

Catalog Number 2C1063KP

Device Problem Inaccurate Delivery (2339)

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

Event Date 03/03/2014

Event Type  malfunction  

Event Description

It was reported that a large volume infusor did not appear to fully deliver its contents.The device was filled with a baxter compounded solution: 8000 mg of flucloxacillin in 240 ml of 0.9% sodium chloride.The device was then connected to a patient for an infusion (treatment for finger pain) expected to last for 24 hours.The reporter stated that at the end of the 24 hours, although the reservoir should have appeared deflated, it was inflated to a larger size than a ¿standard full infusor of 240 ml.¿ a nurse then disconnected the device from the patient, flushed the involved line, found no occlusion, and connected a new infusor to the patient.Later in the same day, the patient reported feeling continued finger pain and severe chest pain, which was not reported before the event.There was no patient injury or medical intervention that was causally related to this event.Additional information was requested and is not available.This is report 1 of 2 for this patient.

Manufacturer Narrative

(b)(4).The lot was manufactured from 10/25/2013 to 10/28/2013.The device was not returned as it was discarded; therefore, an evaluation could not be conducted.A review of all batch record documents was performed with no issues noted during the manufacturing process.There were no deviations from standard procedure and no exceptions related to the reported condition were noted.Should additional relevant information become available, a supplemental report will be submitted.Same patient as (b)(4).

• 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: 3731970
• MDR Text Key: 4312105
• Report Number: 1416980-2014-11331
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: Nurse
• Type of Report: Initial
• Report Date: 03/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 10/01/2016
• Device Catalogue Number: 2C1063KP
• Device Lot Number: 13K088
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2014
• 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: FLUCLOXACILLIN (DBL); 0.9% SODIUM CHLORIDE