MAUDE Adverse Event Report: HOSPIRA COSTA RICA LTD. LC PCA SW VERSION 1.; 80MEA

Catalog Number 20709

Device Problems Incorrect Software Programming Calculations (1495); Use of Device Problem (1670)

Patient Problem No Information (3190)

Event Date 01/01/2014

Event Type  Injury  

Event Description

The customer contact reported a pt-nurse accident.On an unspecified date and time, the device was programmed to deliver an unspecified concentration of dilaudid.No specific programming parameters were provided.After an unspecified length of time, it was reported that there was an event and the pt was admitted to the intensive care unit.No specific event details were provided.At an unspecified time, the customer contact reported that the incorrect concentration of dilaudid was entered into the device and there was an overdelivery.Multiple unsuccessful attempts have been made to obtain add'l info, including specific event details, if any medical interventions were required and the pt outcome.

Manufacturer Narrative

The device was not isolated or identified by serial number; therefore, it will not be returned for investigation.If the device is received, a f/u report will be submitted.Based on the data verified, hospira could not attribute the issue to the device.This report represents all the info known by the reporter upon query by hospira personnel.

• Brand Name: LC PCA SW VERSION 1.
• 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 drive; bldg no. h2-1east, dept no. 097u; lake forest, IL 60045 ; 2242125740
• MDR Report Key: 4137858
• MDR Text Key: 4791057
• Report Number: 9615050-2014-05385
• 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: Nurse
• Type of Report: Initial
• Report Date: 09/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2014
• 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
• Date Manufacturer Received: 09/11/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: DILAUDID, MFR UNK
• Patient Outcome(s): Hospitalization; Required Intervention