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

Catalog Number 20709

Device Problem Thermal Decomposition of Device (1071)

Patient Problem No Patient Involvement (2645)

Event Date 02/20/2014

Event Type  malfunction  

Event Description

The customer contact reported that during testing at the user facility, smoking and burned wires were noted in the device.There were no reports of any adverse pt events and no reported delays of critical therapies while the device was in clinical use.No additional information was provided.

Manufacturer Narrative

Testing and investigation noted smoking and burned wires in the battery compartment.The probable cause of smoking and burned wires is that when the battery was removed and the new battery installed, the insulation to the wires may have been rubbed off exposing the bare wires and when the pump was plugged in, the wires may have been shorted causing the wires to burn.This report represents all the information 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, vice pres ; 275 n field drive; bldg no h2-1east dept no 097u; lake forest, IL 60045 ; 2242125740
• MDR Report Key: 3832813
• MDR Text Key: 16800810
• Report Number: 9615050-2014-02011
• 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: 02/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 20709
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/26/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2011
• 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