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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOSPIRA COSTA RICA LTD. LIFECARE PCA 3 V5.06; 80MEA
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HOSPIRA COSTA RICA LTD. LIFECARE PCA 3 V5.06; 80MEA Back to Search Results
Catalog Number 20709
Device Problems Occlusion Within Device (1423); Failure to Sense (1559)
Patient Problem No Patient Involvement (2645)
Event Date 01/01/2014
Event Type  malfunction  
Event Description
The customer contact reported that during testing at the user facility, the device did not pass the occlusion test.There were no reports of any adverse patient events and no reported delays of critical therapies while the device was in clinical use.No additional information was provided.
 
Manufacturer Narrative
The device has been 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
LIFECARE PCA 3 V5.06
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 Key4251311
MDR Text Key4986558
Report Number9615050-2014-05908
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 10/16/2014
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 Manufacturer10/30/2014
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/16/2014
Initial Date FDA Received11/05/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/01/2006
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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