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

Catalog Number 2C1702KP

Device Problem Filling Problem (1233)

Patient Problem Toxicity (2333)

Event Date 10/03/2016

Event Type  Injury  

Manufacturer Narrative

This lot was manufactured from 06/20/2016 - 06/21/2016.As the sample was not returned a device analysis cannot be completed.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

A patient experienced an overinfusion while connected to a small volume infusor; and the patient subsequently experienced drug toxicity.The device delivered an unspecified dose of an unspecified medication to the patient over a 24 hour period instead of 48 hours.The patient experienced strong drug-toxicity related symptoms (not further specified).It was not reported if the patient was hospitalized for the event.Treatment details and patient outcome were not reported.No additional information is available.

• Brand Name: INFUSOR
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): BAXTER HEALTHCARE - IRVINE; irvine CA
• 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: 6112390
• MDR Text Key: 60305711
• Report Number: 1416980-2016-17433
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 11/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 06/01/2019
• Device Catalogue Number: 2C1702KP
• Device Lot Number: 16F042
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/25/2016
• Initial Date FDA Received: 11/18/2016
• 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
• Treatment: UNSPECIFIED MEDICATION
• Patient Outcome(s): Other