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

Catalog Number 20709

Device Problem Device Inoperable (1663)

Patient Problem No Patient Involvement (2645)

Event Date 04/03/2014

Event Type  malfunction  

Manufacturer Narrative

During testing, the device alarmed with an e630 (screw rotation error) error code.The customer's reported complaint of a malfunction message was duplicated during testing.The device has been identified as part of a product recall.This report represents all the information known by the reporter upon query by hospira personnel.

Event Description

The device was returned to the service center for a report from the customer contact of malfunction message.This does not indicate a reportable malfunction.However, during verification testing at the service center, the device alarmed with an e630 (screw rotation error) error code.

• 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 ; 275 n. field drive; bldg no. h2-1east, dept no. 097u; lake forest, IL 60045 ; 2242125740
• MDR Report Key: 3901981
• MDR Text Key: 22209462
• Report Number: 9615050-2014-03272
• 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: Biomedical Engineer
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 04/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 04/09/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/16/2014
• Initial Date FDA Received: 05/07/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: FA301-02
• Patient Sequence Number: 1