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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ICU MEDICAL, INC. ICU MEDICAL; SET, ADMINISTRATION, INTRAVASCULAR
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ICU MEDICAL, INC. ICU MEDICAL; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number MC100
Device Problems Gas/Air Leak (2946); Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/16/2021
Event Type  malfunction  
Event Description
Liver transplant.I accessed the 3-way stopcock on the patient's central venous pressure (cvp ) (brown port) on her left internal jugular (ij) central line to administer 0900 intravenous pyelogram (ivp) medications for the patient.I detached the iv tubing connected to the microclave clear neutral connector.When the stopcock was open to the microclave clear neutral connector (pressure cap), the rubber inside of the pressure cap was stuck/did not spring back.As a result, an estimated amount of 6-10 ml air entered the patient's cvp.I quickly aspirated the air using an 10 ml syringe and had blood return.The pressure cap was changed, and the line was flushed.Patient's vital signs (vs) were unchanged, no c/o difficulty breathing, was no harm.
 
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Brand Name
ICU MEDICAL
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
ICU MEDICAL, INC.
951 calle amanecer
san clemente CA 92673
MDR Report Key12391107
MDR Text Key268921996
Report Number12391107
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Type of Report Initial
Report Date 08/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberMC100
Device Lot Number5116684
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/29/2021
Event Location Hospital
Date Report to Manufacturer08/31/2021
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/31/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age24090 DA
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