MAUDE Adverse Event Report: HOSPIRA COSTA RICA LTD. LC PCA REFURB 802.11; 80MEA

Catalog Number 20709

Device Problem Device Inoperable (1663)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/07/2014

Event Type  malfunction  

Event Description

The customer contact reported the device alarmed with an e630 (screw rotation error) malfunction alarm code.The device was returned to the biomedical department with an unsigned and undated note stating, "screen says malfunction, turn in for service." no info was provided; therefore, specific pt info, device 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, an e630 (screw rotation error) malfunction alarm code was noted in the device history.No additional info was provided.

Manufacturer Narrative

The device mechanism has been received.Investigation is not complete.This report represents all the information known by the reporter upon query by hospira personnel.

• Brand Name: LC PCA REFURB 802.11
• 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: 4113819
• MDR Text Key: 15809632
• Report Number: 9615050-2014-05266
• 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
• Type of Report: Initial
• Report Date: 08/26/2014

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: 09/05/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/26/2014
• Initial Date FDA Received: 09/17/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/01/2007
• 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