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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 Consequences Or Impact To Patient (2199)
Event Date 01/01/2014
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 with a note that stated, "error on the pump." 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.Though requested, no additional information was provided.
 
Manufacturer Narrative
The device was received.Investigation is not complete.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 de heredia
CS 
Manufacturer (Section G)
HOSPIRA COSTA RICA LTD.
zona franca global
la aurora de 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 Key3822905
MDR Text Key4398205
Report Number9615050-2014-00915
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
Type of Report Initial
Report Date 01/01/2014
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
Date Returned to Manufacturer01/23/2014
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/10/2014
Initial Date FDA Received02/05/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/01/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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