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U.S. Department of Health and Human Services

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

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HOSPIRA COSTA RICA LTD. LC PCA HOSPIRA MEDNE; 80MEA Back to Search Results
Catalog Number 20709
Device Problem Device Inoperable (1663)
Patient Problem No Patient Involvement (2645)
Event Date 03/01/2014
Event Type  malfunction  
Event Description
The device was returned to the service center for a report from the customer contact of an unspecified malfunction.However, during verification testing at the service center, the device alarmed with an e630 (screw rotation error) error code.
 
Manufacturer Narrative
During testing, the device alarmed with an e360 (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.
 
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Brand Name
LC PCA HOSPIRA MEDNE
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. h2-1east, dept no. 097u
lake forest, IL 60045
2242125740
MDR Report Key3970784
MDR Text Key4636024
Report Number9615050-2014-03066
Device Sequence Number1
Product Code MEA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K042800
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Remedial Action Recall
Type of Report Initial
Report Date 03/26/2014
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 Number20709
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/04/2014
Initial Date FDA Received04/29/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/01/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction NumberFA301-02
Patient Sequence Number1
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