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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ICU MEDICAL, INC. ICU MEDICAL SPIROS; CLOSED HAZARDOUS DRUG RECONSTITUTION
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ICU MEDICAL, INC. ICU MEDICAL SPIROS; CLOSED HAZARDOUS DRUG RECONSTITUTION Back to Search Results
Model Number CH3556
Device Problems Break (1069); Fluid/Blood Leak (1250)
Patient Problem Blood Loss (2597)
Event Date 09/08/2020
Event Type  malfunction  
Event Description
Patient was running fluids attached to a spiros filter that was hooked up to the central line.Patient pulled on line and filter tubing broke right at the spiros connection, still activating the neutron cap on the central line, so blood began to flow from the broken connection.Rn clamped line, blood cultures were ordered and drawn.
 
Event Description
Patient was running fluids attached to a spiros filter that was hooked up to the central line.Patient pulled on line and filter tubing broke right at the spiros connection, still activating the neutron cap on the central line, so blood began to flow from the broken connection.Rn clamped line, blood cultures were ordered and drawn.
 
Event Description
Patient was running fluids attached to a spiros filter that was hooked up to the central line.Patient pulled on line and filter tubing broke right at the spiros connection, still activating the neutron cap on the central line, so blood began to flow from the broken connection.Rn clamped line, blood cultures were ordered and drawn.
 
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Brand Name
ICU MEDICAL SPIROS
Type of Device
CLOSED HAZARDOUS DRUG RECONSTITUTION
Manufacturer (Section D)
ICU MEDICAL, INC.
951 calle amanecer
san clemente CA 92673
MDR Report Key10704167
MDR Text Key212109276
Report Number10704167
Device Sequence Number1
Product Code ONB
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,Followup,Followup
Report Date 09/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/20/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberCH3556
Device Lot Number4461396
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/11/2020
Event Location Hospital
Date Report to Manufacturer10/20/2020
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age365 DA
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