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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOSPIRA COSTA RICA LTD. LC PCA REFURB 802.1; 80MEA

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HOSPIRA COSTA RICA LTD. LC PCA REFURB 802.1; 80MEA Back to Search Results
Catalog Number 20709
Device Problem Device Inoperable (1663)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/01/2013
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 an unsigned note that stated, "urgent device field correction".No tracking info was provided; therefore, specific pt info, pump 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.No add'l info was provided.
 
Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.This report represents all the info known by the reporter upon query by hospira personnel.
 
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Brand Name
LC PCA REFURB 802.1
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, gps
275 n. field drive
bldg no. h2-1east, dept no. 097u
lake forest, IL 60045
2242125740
MDR Report Key3874511
MDR Text Key4506290
Report Number9615050-2014-02871
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 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 03/26/2014
Initial Date FDA Received04/22/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/01/2009
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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