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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOSPIRA COSTA RICA LTD. LC PCA NEW 802.11 AB; 80MEA

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HOSPIRA COSTA RICA LTD. LC PCA NEW 802.11 AB; 80MEA Back to Search Results
Catalog Number 20709
Device Problem Device Inoperable (1663)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/17/2014
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 dept with a note that stated, "malfunction".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.During testing at the user facility, the device alarmed with an e630 (screw rotation error) error code.No add'l info was provided.
 
Manufacturer Narrative
The device passed testing.An e360 (screw rotation error) error code was noted in the device history but was not duplicated during testing.Although the device passed testing, 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.
 
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Brand Name
LC PCA NEW 802.11 AB
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, vice pres
275 n. field dr
bldg. no. h2-1east, dept no. 097u
lake forest, IL 60045
2242125740
MDR Report Key3861068
MDR Text Key4506866
Report Number9615050-2014-02671
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 Biomedical Engineer
Remedial Action Recall
Type of Report Initial
Report Date 03/18/2014
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 Manufacturer03/27/2014
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/18/2014
Initial Date FDA Received04/14/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/01/2008
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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