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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ICU MEDICAL, INC. ICU MEDICAL; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR
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ICU MEDICAL, INC. ICU MEDICAL; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR Back to Search Results
Model Number 46080-57
Device Problems Disconnection (1171); Reflux within Device (1522)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 09/23/2021
Event Type  malfunction  
Event Description
Arterial line tubing was connected to patient.About 5 minutes later, the rn at bedside noticed blood backing up in the arterial line.Assessing the system, the rn checked all connections that should come apart and they were secure.The tubing had come apart from a blood sampling port.The patient had 10 ml of blood loss.The rn immediately changed out the tubing for a new setup.The arterial line setup was just out of packaging.Manufacturer response for transducer, blood-pressure, extravascular, icu medical (per site reporter).Sent a list of questions for me to respond to.
 
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Brand Name
ICU MEDICAL
Type of Device
TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR
Manufacturer (Section D)
ICU MEDICAL, INC.
951 calle amanecer
san clemente CA 92673
MDR Report Key12575821
MDR Text Key274733582
Report Number12575821
Device Sequence Number1
Product Code DRS
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 10/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/05/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number46080-57
Device Catalogue Number460800457
Device Lot Number5206543
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/04/2021
Event Location Hospital
Date Report to Manufacturer10/05/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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