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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ICU MEDICAL, INC. REM MICROCLAVE SET, ADMINISTRATION, INTRAVASCULAR

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ICU MEDICAL, INC. REM MICROCLAVE SET, ADMINISTRATION, INTRAVASCULAR 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 07/07/2016
Event Type  malfunction  
Event Description
Iv pump set up for iv infusion with ivpb. The pump alarmed for air-in-line. The rn checked tubing and verified. Detected air and iv fluids throughout tubing, including pressure infusion extension set with remv microclave clear rotating luer. Unsure if air reached patient. Iv infusion pump was alarming, but air and iv fluids was detected intermittently throughout entire tubing line. The pump was removed from room and exchanged for new infusion pump. Work order completed by rn.
 
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Brand NameREM MICROCLAVE
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
ICU MEDICAL, INC.
4455 atherton dr.
salt lake city UT 84123
MDR Report Key6036454
MDR Text Key57734621
Report Number6036454
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 09/19/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/18/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/19/2016
Event Location Hospital
Date Report to Manufacturer09/19/2016
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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