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Adverse Event Report

BAXTER HEALTHCARE CONTINUE FLO SOLUTION SET INTRAVENOUS FLUID ADMINISTRATION TUBING   back to search results
Catalog Number 2C6537S
Device Problems Valve(s), failure of; Device failure
Event Date 03/05/2004
Patient Outcome  Life Threatening;
Event Description

"back flow" valve failed. Three iv piggyback medications were given from 5 pm till 10:45 pm. At 11 pm the nurse caring for the pt noticed that the maintenance iv solution bag was getting bigger/fatter.

 
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Brand NameCONTINUE FLO SOLUTION SET
Type of DeviceINTRAVENOUS FLUID ADMINISTRATION TUBING
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
BAXTER HEALTHCARE
deerfield IL *
Manufacturer (Section D)
BAXTER HEALTHCARE
deerfield IL *
Device Event Key504873
MDR Report Key515862
Event Key489443
Report Number515862
Device Sequence Number1
Product CodeFPA
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 03/09/2004
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/10/2004
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number2C6537S
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/09/2004
Distributor Facility Aware Date03/05/2004
Event Location Hospital
Date Report TO Manufacturer03/09/2004
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?

Database last updated on January 30, 2009

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