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

Catalog Number 20709

Device Problem Device Inoperable (1663)

Patient Problem No Patient Involvement (2645)

Event Date 08/18/2014

Event Type  malfunction  

Event Description

The customer contact reported during preventive maintenance at the user facility, the device audibly alarmed error 640 (screw rotation error).There were no reports of any adverse patient events or delays in critical therapies while the device was in clinical use.No additional information was provided.

Manufacturer Narrative

The device was received.Investigation is not complete.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 HOLDINGS DE COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• Manufacturer (Section G): HOSPIRA HOLDINGS DE 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: 4142678
• MDR Text Key: 4911221
• Report Number: 9615050-2014-05388
• 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
• Type of Report: Initial
• Report Date: 09/09/2014

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?: 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: 09/16/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/09/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/01/2011
• 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