MAUDE Adverse Event Report: HOSPIRA COSTA RICA LTD. LC PCA HOSPIRA MEDNE; 80MEA

Catalog Number 20709

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Decreased Respiratory Rate (2485)

Event Date 03/02/2015

Event Type  Injury  

Event Description

The customer contact reported an adverse event while the device was in use.At an unspecified time the device was programmed to deliver fentanyl 10 mcg/hr at a continuous rate.Prior to the start of the delivery, it was reported that the pt received a 10 mcg bolus dose of fentanyl.Approx 4 hours after the delivery was started, the pt was found experiencing respiratory depression.At that time, a rapid response was called to the floor.The customer contact reported that the pt was treated with two unspecified doses of narcan and responded well.No specific event details were provided.The customer contact reported that the device did not contribute to the event.It was reported that the pt was over-sensitive to the fentanyl.During testing at the user facility, the device passed testing and the device history indicated the device delivered as programmed.No additional info was provided.

Manufacturer Narrative

At this time the customer will not be returning the device for eval.The device passed testing at the user facility and was returned to clinical service.If the device is received, a follow up report will be submitted.This report represents all info known by the reporter upon query by hospira personnel.

• Brand Name: LC PCA HOSPIRA MEDNE
• Type of Device: 80MEA
• Manufacturer (Section D): HOSPIRA COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• Manufacturer (Section G): HOSPIRA COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• Manufacturer Contact: juergen schmider, md, vp, gps ; 275 n field dr; bldg no h2-1east dept no 097u; lake forest, IL 60045 ; 2242125740
• MDR Report Key: 4623239
• MDR Text Key: 5587865
• Report Number: 9615050-2015-00729
• Device Sequence Number: 1
• Product Code: MEA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042800
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/03/2015

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: 20709
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/03/2015
• Initial Date FDA Received: 03/19/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: FENTANYL
• Patient Outcome(s): Required Intervention