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

Catalog Number 12384

Device Problems Loss of Power (1475); Device Inoperable (1663)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/21/2014

Event Type  malfunction  

Event Description

The customer contact reported that the device shuts off on its own and an e630 (screw rotation error) error code was noted.The device was returned to the biomedical department with a signed note that stated, "shuts off won't turn back on".No tracking info was provided; therefore, specific pt info, pump programming, or event details were not available.There were no reports of any adverse pt events or delays in critical therapies while the device was in clinical use.During testing at the user facility, the device shut off on its own and an e630 (screw rotation error) error code was noted.No additional info was provided.

Manufacturer Narrative

The device was received.Investigation is not complete.This report represents all the info known by the reporter upon query by hospira personnel.

• Brand Name: LC PCA III INFUSER
• 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 dr; lake forest, IL 60045 ; 2242125740
• MDR Report Key: 4142950
• MDR Text Key: 4948474
• Report Number: 9615050-2014-05196
• Device Sequence Number: 1
• Product Code: MEA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043256
• 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: 08/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 12384
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/02/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/22/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/01/2003
• 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