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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ICU MEDICAL INC 60 INCH SMALL BORE EXT SET WITH CLAMP LEUR LOCK; IV TUBING EXTENSION SET
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ICU MEDICAL INC 60 INCH SMALL BORE EXT SET WITH CLAMP LEUR LOCK; IV TUBING EXTENSION SET Back to Search Results
Catalog Number B2032
Device Problems Air Leak (1008); Material Integrity Problem (2978)
Patient Problems Air Embolism (1697); Death (1802)
Event Date 04/12/2016
Event Type  Death  
Event Description
Pt to operating room in plans of conversion of ecmo to a lvad.Perfusion noted dramatic changes in ecmo flows.Large amount of air noted in both arterial and venous limbs of ecmo circuit with no perfusion.Cpr initiated, ecmo cannulae attempted to be purged of air by perfusion staff.However, due to massive air embolus resuscitation unsuccessful.After discussion with cicu, transplantation service, anesthesia, a decision was made not to proceed with any additional measures.Pt pronounced and family care conference was held with pt's mother.The iv tubing line attached to the venous luer port, suffered a loss in tubing integrity that offered an opportunity to entrain air into the ecmo circuit.Air displaced blood in the circuit traveling to the cannulation site.
 
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Brand Name
60 INCH SMALL BORE EXT SET WITH CLAMP LEUR LOCK
Type of Device
IV TUBING EXTENSION SET
Manufacturer (Section D)
ICU MEDICAL INC
951 calle amanecer
san clemente CA 92673
MDR Report Key5596973
MDR Text Key43313671
Report Number5596973
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 Patient
Type of Report Initial
Report Date 04/14/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/22/2016
Is this an Adverse Event Report? Yes
Device Operator Other
Device Catalogue NumberB2032
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/14/2016
Device Age1 DY
Event Location Hospital
Date Report to Manufacturer04/14/2016
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
Patient Outcome(s) Death;
Patient Age2 YR
Patient Weight9
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