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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ICU MEDICAL TEGO CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR

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ICU MEDICAL TEGO CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number D1000
Device Problem Disconnection (1171)
Patient Problems Bradycardia (1751); Death (1802)
Event Date 01/06/2020
Event Type  Death  
Event Description
Continuous renal replacement therapy (crrt) in progress. Patient noted to be acutely bradycardic. Observed blood on the left side of the patient, patient found to be disconnected from crrt machine. Pressure was applied and catheters clamped, but heart rate continued to drop. Patient expired. The filter circuit on the patient return line found to be disconnected from the tego connector, which was attached to the patient's catheter. The disconnection occurred between the two products - the prismaflex set and the yellow tego connector. The tego connector attached to the vascath remained in place when the deceased was transferred for autopsy. The prismaflex circuit was sequestered and sent to the manufacturer for interrogation. The disconnection of the return line was not detectable, as the crrt default alarm parameters were not met. Suggested software enhancements for the manufacturer to explore: include incorporating rate/percentage based alarms for the return line.
 
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Brand NameTEGO CONNECTOR
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
ICU MEDICAL
951 calle amanecer
san clemente CA 92673
MDR Report Key9749953
MDR Text Key180731186
Report Number9749953
Device Sequence Number1
Product Code FPA
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 02/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/25/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberD1000
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/19/2020
Event Location Hospital
Date Report to Manufacturer02/25/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 02/25/2020 Patient Sequence Number: 1
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