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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ICU MEDICAL 5 GANG 4-WAY NANOCLAVE STOPCOCK WITH BASEPLATE, ROTATING LUER; STOPCOCK, I.V. SET
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ICU MEDICAL 5 GANG 4-WAY NANOCLAVE STOPCOCK WITH BASEPLATE, ROTATING LUER; STOPCOCK, I.V. SET Back to Search Results
Model Number AC205
Device Problem Break (1069)
Patient Problems Cardiopulmonary Arrest (1765); Death (1802); Loss Of Pulse (2562)
Event Date 06/28/2020
Event Type  Death  
Event Description
From staff: extremely critical post-operative emergency coronary artery bypass graft patient was transported to ct via bed.On return to patient room loss of arterial pulsatile flow noted.Standard treatment initiated which included fluid bolus.Trouble shooting of patient setup demonstrated that a clc broke off iv manifold sometime during or on return from ct trip.This breaking of iv apparatus resulted in patient not receiving high dose, high strength vasoactive and lifesaving medications.Stable iv flow was re-established, but patient found to be in pulseless electrical activity.Code blue initiated.Patient expired despite heroic efforts.
 
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Brand Name
5 GANG 4-WAY NANOCLAVE STOPCOCK WITH BASEPLATE, ROTATING LUER
Type of Device
STOPCOCK, I.V. SET
Manufacturer (Section D)
ICU MEDICAL
951 calle amanecer
san clemente CA 92673
MDR Report Key10337770
MDR Text Key200803696
Report Number10337770
Device Sequence Number1
Product Code FMG
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/29/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberAC205
Device Lot Number4161156
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/24/2020
Event Location Hospital
Date Report to Manufacturer07/29/2020
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age25915 DA
Patient Weight120
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