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

Catalog Number 2C1155KP

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Discomfort (2330); Malaise (2359)

Event Date 12/20/2018

Event Type  malfunction  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

A patient experienced feelings of being very sick after a use error occurred with a multirate infusor.It was reported the nurse primed the bd line with 20mg/ml of morphine and adjusted the multirate dosage at 3ml/hr which resulted in the home patient receiving 60mg/hr of morphine.The physician¿s prescription was a dosage of 4 milligrams per hour.It was reported the nurse ¿forgot¿ she was using this infusor as they were used to using another device.After the patient received the dosage they felt very sick and subsequently received naloxone (no further details).It was reported the patient felt better and the ¿condition of health was eventually normal¿.No additional information is available.

Manufacturer Narrative

The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.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; irvine CA
• MDR Report Key: 8453251
• MDR Text Key: 139892449
• Report Number: 1416980-2019-01594
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/06/2019

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 2C1155KP
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/28/2019
• Initial Date FDA Received: 03/26/2019
• Supplement Dates Manufacturer Received: 04/29/2019
• Supplement Dates FDA Received: 05/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BD 100 CM 3 WAY STOPCOCK; BD 100 CM 3 WAY STOPCOCK
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR