MAUDE Adverse Event Report: HOSPIRA COSTA RICA LTD. LIFECARE PCA 3 V5.06; 80MEA

Catalog Number 20709

Device Problem Device Inoperable (1663)

Patient Problem No Patient Involvement (2645)

Event Date 11/06/2013

Event Type  malfunction  

Event Description

The customer contact reported the device alarmed with an e630 (screw rotation error) error code.The device was returned to the biomedical department for a report of device alarmed 630.No tracking information was provided; therefore, specific patient information, pump programming, or event details were not available.There were no reports of any adverse patient events or delays in critical therapies while the device was in clinical use.During testing at the user facility, the device alarmed with an e630 (screw rotation error) error code.No additional information was provided.

Manufacturer Narrative

A field service engineer performed testing and investigation at the user facility.During testing, the device alarmed with an e630 (screw rotation error) error code.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.

• Brand Name: LIFECARE PCA 3 V5.06
• 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: 3901966
• MDR Text Key: 20019299
• Report Number: 9615050-2014-01375
• 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,Company Representative
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 01/25/2014

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: 01/27/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/25/2014
• Initial Date FDA Received: 02/20/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2006
• 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