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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION UNKNOWN; CATHETER, UMBILICAL ARTERY
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BAXTER HEALTHCARE CORPORATION UNKNOWN; CATHETER, UMBILICAL ARTERY Back to Search Results
Device Problems Air Leak (1008); Device Displays Incorrect Message (2591)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/28/2016
Event Type  malfunction  
Event Description
Flushed lipids through tubing and filter to prime tubing/filter before connecting to patient.The tubing and filter was checked by two rns to ensure no air in tubing.After tubing connected to patient's umbilical arterial catheter and started running at 0.2 ml/hr.I went to bedside to assess patient because pump alarming resistance in line.A large air bubble of approximately 2 ml was emerging from the distal end of filter (on the patient side).Lipids disconnected and air flushed through before reconnecting to patient, per rn.The device was not retained.No identifying information is available.
 
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Brand Name
UNKNOWN
Type of Device
CATHETER, UMBILICAL ARTERY
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
25212 w. illinois route 120
rlt-10
round lake IL 60073
MDR Report Key5821846
MDR Text Key50411948
Report Number5821846
Device Sequence Number1
Product Code FOS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 06/03/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/26/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Unknown
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/03/2016
Event Location Hospital
Date Report to Manufacturer06/03/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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