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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ICU MEDICAL, INC. ICU MEDICAL 7" EXTENSION SET WITH REMV MICROCLAVE IV EXTENSION TUBING; STOPCOCK, I.V. SET
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ICU MEDICAL, INC. ICU MEDICAL 7" EXTENSION SET WITH REMV MICROCLAVE IV EXTENSION TUBING; STOPCOCK, I.V. SET Back to Search Results
Model Number 12515-01
Device Problem Disconnection (1171)
Patient Problem Cardiac Arrest (1762)
Event Type  Injury  
Event Description
Patient was having a cardiac catheterization for an acute ml.During the procedure a heparin bolus was given.The cardiologist noted thrombi building up around the cardiac wires while performing procedure.Act level returned as normal and should have read high after receiving the heparin.The iv site and connections were checked beneath the sterile drapes and it was found that the iv tubing had become disconnected from the iv extension tubing.Due to the patient not receiving any anticoagulants thrombi form within the cardiac artery, this resulted in a cardiac arrest.Resuscitation efforts were not successful and the patient died.A week later another patient was having a procedure performed in the cardiac cath lab.After the procedure it was discovered the iv extension tubing had become disconnected from the hub of the iv catheter.This is new product to our facility.Upon querying the staff who have used this product we found that it easily becomes disconnected from the iv tubing.Reference report mw5115696.
 
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Brand Name
ICU MEDICAL 7" EXTENSION SET WITH REMV MICROCLAVE IV EXTENSION TUBING
Type of Device
STOPCOCK, I.V. SET
Manufacturer (Section D)
ICU MEDICAL, INC.
951 calle amanecer
san clemente CA 92673
MDR Report Key16530578
MDR Text Key311242959
Report NumberMW5115697
Device Sequence Number1
Product Code FMG
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 03/08/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/10/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number12515-01
Device Catalogue NumberPHD12-3684 REV 03
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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