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 04/15/2014

Event Type  malfunction  

Event Description

During preventive maintenance testing at the user facility, the device alarmed with the e630 (screw rotation error) error code.There were no reports of any adverse pt events or delays in critical therapies while the device was in clinical use.No additional info was provided.

Manufacturer Narrative

At this time the customer will not be returning the device for eval.The customer contact stated the device will be repaired at the user facility.If the device is received, a follow up report will be submitted.The device has been identified as part of a product recall.This report represents all the info 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 ; 275 n field dr; bldg no. h2-1e, dept no. 097u; lake forest, IL 60045 ; 2242125740
• MDR Report Key: 3969724
• MDR Text Key: 4612770
• Report Number: 9615050-2014-03254
• 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: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 04/15/2014

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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/15/2014
• Initial Date FDA Received: 05/06/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2006
• 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