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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 03/20/2014
Event Type  malfunction  
Event Description
The customer contact reported an e630 (screw rotation error) error code was noted.The device was returned to the biomedical department with an unsigned note that stated, "malfunction".No tracking info was provided; therefore, specific patient info, 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, an e630 (screw rotation error) error code was noted.No add'l info was provided.
 
Manufacturer Narrative
The device was rec'd.Investigation is not complete.This report represents all the info 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 drive
bldg no h2-1east dept no 097u
lake forest, IL 60045
2242125740
MDR Report Key3964069
MDR Text Key4607024
Report Number9615050-2014-03206
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 04/09/2014
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 Manufacturer04/29/2014
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/09/2014
Initial Date FDA Received05/05/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/01/2011
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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